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Introduction to FDA Audits

The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act. This typically involves an investigator visiting a firm’s location. Learn about the basics of FDA Audits with this starter Qstream microlearning course.

Category: Compliance

Industry: Pharmaceutical

Questions: 15

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Introduction to FDA Audits

Navigate through the Qstream questions below to preview. Each challenge is designed following Qstream’s best practices for maximum knowledge reinforcement and engagement. This Qstream is free for clients to use as a starting point.

1. Types of FDA Inspections >
2. Pre- and Post-Approval FDA Inspections >
3. Inspector NIPP Protocol >
4. Systems Included In A Surveillance Inspection >
5. An Abbreviated Inspection >
6. Additional Types of FDA Inspections >
7. FDA Inspection Team Specialties >
8. FDA Inspection Plans >
9. Inspector Credentials >
10. Daily Inspection Activities >
11. Good Manufacturing Practice Violations >
12. Inspector Documentation & Data Integrity >
13. FDA Inspection Categories >
14. FDA Inspection Report Conclusions >
15. Repeatedly Passing FDA Inspections >

Follow the interactions on each screen to answer Qstream questions as a Participant.

Sarah, a manager at ACME Global Pharmaceuticals, just heard from one of her colleagues that they will be receiving an FDA (Food and Drug Administration) inspection soon. When she informs her team in her next staff meeting, one of them asks if the company did something wrong or is in trouble. Sarah reassures the team that this is a routine surveillance inspection to make sure ACME is following Good Manufacturing Practices (GMP).

Which of the following are other major types of FDA inspections?

Answer explanation:
FDA (Food and Drug Administration) inspections are an official examination of a facility to determine its compliance with laws and regulations administered by the FDA. These inspections are characterized by a focus on:
• Fact-finding
• Obtaining evidence
• Compliance with regulations

The four types of major Good Manufacturing Practices (GMP) inspections that the FDA conducts include:
• Pre-approval
• Post-approval
• Surveillance (routine)
• For-cause or directed

Corey is a product owner of a new drug, AbleMax, that his company is launching. Last quarter, they passed their Pre-Approval Inspection (PAI) from the FDA (Food and Drug Administration). When they began production, they needed to upgrade some of their equipment to accommodate anticipated higher demand. Now that they have been producing AbleMax for three months, Corey is preparing his team for the post-approval inspection.

When discussing the upcoming post-approval inspection with his team, Cory should focus on making sure they understand which of the following?

Answer explanation:
The Pre-Approval Inspection (PAI) assures the FDA (Food and Drug Administration) that a manufacturing establishment named in a drug application is capable of manufacturing a drug and that the submitted data are accurate and complete.

Since Corey’s team has already met this benchmark, the FDA will next conduct a Post-Approval Inspection of their product (AbleMax) and monitor for changes in the production and control practices since the PAI. In this case, there have been changes in the production because some of the equipment has been upgraded and Corey’s team should be knowledgeable in the current configuration.

Theodore is an experienced and seasoned FDA (Food and Drug Administration) inspector. When he first started conducting inspections many years ago, the protocols were different than they are today. Now he uses the New Inspection Protocol Project (NIPP) protocol to conduct surveillance inspections.

Which of the following are characteristics of the NIPP protocol?

Answer explanation:
The New Inspection Protocol Project (NIPP) is a new paradigm for inspections and reports designed to advance pharmaceutical quality. The main feature is the standardized approach to inspection where data is gathered to inform quality intelligence of sites and products.

When using the NIPP, Theodore needs to record both positive and negative behaviors. He uses expert questions to explore both risk-based and rule-based processes. Theodore also uses semi-quantitative scoring, which allows him to compare within and between sites.

Which of the following systems are covered in an FDA (Food and Drug Administration) surveillance inspection?

Answer explanation:
Activities in pharmaceutical companies can be organized into systems (sets of operations and related activities). Control of all systems will help ensure production of drugs that meet intended safety, identity, strength, quality, and purity characteristics.

According to 21 CFR 211, there are six systems that are covered in an FDA (Food and Drug Administration) surveillance inspection:
• Quality
• Facilities and equipment
• Materials
• Production
• Packaging and labeling
• Laboratory controls

Owen was fairly stressed out the last time his pharmaceutical lab received an FDA (Food and Drug Administration) surveillance inspection. Although they were approved, it was a very thorough, full inspection that covered four systems. Since then, their product and equipment have not changed. However, it is almost time for the next inspection, and Owen is considering the type of inspection that will be required.

Owen anticipates it will most likely be an abbreviated inspection because _______.

Answer explanation:
There are two surveillance inspection options: full and abbreviated.

A full inspection covers the quality system plus three other systems. It is required during an initial inspection or when there has been a history of noncompliance. It is also used when there are significant changes such as new technologies, equipment, or facilities.

An abbreviated inspection is meant to provide an efficient update evaluation of an organization’s Good Manufacturing Practices (GMP) compliance. This is usually conducted when:
• An organization has a record of satisfactory GMP compliance
• There are no significant recalls, product defects, or field alert incidents
• The manufacturing profile has not changed substantially within the previous two years

Last quarter, TCM Global Laboratories had to recall 100,000 units of their blood pressure regulation medicines due to a manufacturing error. All of the units were recovered before they were used by customers.

Due to this error, the FDA will most likely conduct a _________ inspection.

Answer explanation:
For-cause or directed inspections are used for anything other than pre-approval, post-approval, or routine surveillance inspections. For example, they are used when there is a need to investigate a specific problem that has come to the FDA’s (Food and Drug Administration) attention, such as TCM Global Laboratory’s product recall. For-cause or directed inspections are also used if there has been an NDA (New Drug Application) Field Alert report or an adverse event cluster.

Louise will conduct a full surveillance inspection at a pharmaceutical laboratory in two weeks. She must gather and coordinate a team to conduct the inspection because there is a lot of work to do and various specialties are required to address the multiple systems under review.

Which of the following specialties are often included in an FDA inspection team?

Answer explanation:
Section 704(a) of the FD&C (Federal Food, Drug, and Cosmetic) Act provides authority for the FDA to conduct inspections “upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge.”

Louise knows she must be reasonable in her time, limits, and manner of the objective inspection. To meet this standard, she will work with a team of experts in other specialty areas such as chemistry, microbiology, process/facility, and formulation.

Miguel is creating a plan for a directed inspection of Tobias Laboratories next week. As part of his due diligence, he is viewing documentation from which of the following sources?

Answer explanation:
Miguel’s inspection plan should be based on the following information:
• Previous Establishment Inspection Reports (EIRs)
• Previous FDA Form 483 observations and their related responses, warning letters, and/or related firm commitments
• The company’s website including product literature, products manufactured, and recent press releases
• Consumer complaints and recalls since the last inspection

Lakshmi is meeting Clint, the lead FDA inspector, on the morning of the first day of inspections at LG Manufacturing. As the agent in charge, Lakshmi wants to ensure that Clint’s documentation is in order.

Which of the following is Lakshmi permitted to do?

Answer explanation:
Clint is required by law to show his credentials upon starting an inspection to the top management official such as owner, operator, or agent in charge. Management may examine the investigators’ credentials and record the name(s) and phone number(s). However, credentials are not to be copied in any manner.

FDA inspections tend to be multi-day processes. At the end of each day, the lead inspector will typically:

Answer explanation:
On-site FDA inspections follow a standardized process in which the lead investigator will:
1. Issue a notice of inspection
2. Display credentials, state the purpose of inspection, and provide a general agenda
3. Tour the facility
4. Get into the details of the inspection
5. Hold a daily wrap-up meeting

Melissa, a senior manager at Ethan Pharmaceuticals, is having her monthly meeting with her mentor, Santiago. She was promoted to her new role less than three months ago and has questions about an upcoming FDA surveillance inspection (she has never been responsible for overseeing one). She asks Santiago about common violations that she should be aware of so she can address them before they become a problem.

Which of the following are common Good Manufacturing Practice (GMP) violations that Santiago could reference?

Answer explanation:
During an FDA inspection, inspectors are verifying that manufacturers like Ethan Pharmaceuticals are operating in a sufficient state of control by reference to the Good Manufacturing Practice (GMP) regulations and policies. If that is not found to be the case, inspectors must document accordingly to support the necessary action.

Common GMP violations include:
• Poorly trained employees
• Poorly maintained or contaminated equipment and facilities
• Lack of process control
• Failure to conduct investigations and resolve any discrepancies, failures, deviations, or complaints

Veronica is meeting with her team of FDA inspectors to prepare for an inspection at JLP Global the following day. Her team will focus on identifying any data integrity issues.

Veronica states that a big red flag indicating underlying problems is when activities are not recorded _________.

Answer explanation:
Investigators look for documentation and data integrity issues during their inspections. Some of the issues Veronica’s team will look out for include:
• Activities not being recorded contemporaneously
• Fabricating data to create acceptable test results
• Discarding data without appropriate documentation
• Data that looks too good to be true
• Lack of raw data (i.e., sample weights, sample solution prep)

Her team will ask those in charge at JLP Global to review documentation of past events as well as scientific evidence to support JLP Global’s conclusions.

When an inspection ends, it is generally classified into one of three categories:
• No Action Indicated
• Voluntary Action Indicated
• ________ Action Indicated

Answer explanation:
The three categories of inspections are:
• NAI- No Action Indicated
• VAI- Voluntary Action Indicated
• OAI- Official Action Indicated

The inspection report must be completed and provided to the organization that was inspected in a timely manner and incorporate all inspectional findings from each team member.

FDA (Food and Drug Administration) Inspection report conclusions can include which of the following?

Answer explanation:
The FDA’s (Food and Drug Administration) Field Medical Directive 86 (FMD-86) outlines that the conclusions and decisions of an inspection report can include:
• Voluntary actions
• Advisory actions (i.e., warning letters, untitled letters)
• Legal sanctions (i.e., seizure, injunction, prosecution)
• Recognition of positive behaviors

For more information, check out the FDA Field Management Directives:
http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM382035.pdf

Kendra’s team just passed their Pre-Approval Inspection (PAI). She explains that in a few months, they will undergo their Post-Approval Inspection.
To ensure another successful FDA (Food and Drug Administration) inspection, Kendra and her team must all do their part, including:

Answer explanation:
To be prepared for an FDA (Food and Drug Administration) inspection, it is recommended to do the following:
• Know and comply with FDA regulations and policies
• Always follow SOPs (Standard Operating Procedures)
• Ask the investigator for clarification if you don’t understand or agree with an observation
• Be proactive and have a good attitude
• Display a willingness to correct problems, but do not promise to make a correction if you do not agree with it or are not sure that you will be able to follow through

Sarah, a manager at ACME Global Pharmaceuticals, just heard from one of her colleagues that they will be receiving an FDA (Food and Drug Administration) inspection soon. When she informs her team in her next staff meeting, one of them asks if the company did something wrong or is in trouble. Sarah reassures the team that this is a routine surveillance inspection to make sure ACME is following Good Manufacturing Practices (GMP).

Which of the following are other major types of FDA inspections?

Answer explanation:
FDA (Food and Drug Administration) inspections are an official examination of a facility to determine its compliance with laws and regulations administered by the FDA. These inspections are characterized by a focus on:
• Fact-finding
• Obtaining evidence
• Compliance with regulations

The four types of major Good Manufacturing Practices (GMP) inspections that the FDA conducts include:
• Pre-approval
• Post-approval
• Surveillance (routine)
• For-cause or directed

Corey is a product owner of a new drug, AbleMax, that his company is launching. Last quarter, they passed their Pre-Approval Inspection (PAI) from the FDA (Food and Drug Administration). When they began production, they needed to upgrade some of their equipment to accommodate anticipated higher demand. Now that they have been producing AbleMax for three months, Corey is preparing his team for the post-approval inspection.

When discussing the upcoming post-approval inspection with his team, Cory should focus on making sure they understand which of the following?

Answer explanation:
The Pre-Approval Inspection (PAI) assures the FDA (Food and Drug Administration) that a manufacturing establishment named in a drug application is capable of manufacturing a drug and that the submitted data are accurate and complete.

Since Corey’s team has already met this benchmark, the FDA will next conduct a Post-Approval Inspection of their product (AbleMax) and monitor for changes in the production and control practices since the PAI. In this case, there have been changes in the production because some of the equipment has been upgraded and Corey’s team should be knowledgeable in the current configuration.

Theodore is an experienced and seasoned FDA (Food and Drug Administration) inspector. When he first started conducting inspections many years ago, the protocols were different than they are today. Now he uses the New Inspection Protocol Project (NIPP) protocol to conduct surveillance inspections.

Which of the following are characteristics of the NIPP protocol?

Answer explanation:
The New Inspection Protocol Project (NIPP) is a new paradigm for inspections and reports designed to advance pharmaceutical quality. The main feature is the standardized approach to inspection where data is gathered to inform quality intelligence of sites and products.

When using the NIPP, Theodore needs to record both positive and negative behaviors. He uses expert questions to explore both risk-based and rule-based processes. Theodore also uses semi-quantitative scoring, which allows him to compare within and between sites.

Which of the following systems are covered in an FDA (Food and Drug Administration) surveillance inspection?

Answer explanation:
Activities in pharmaceutical companies can be organized into systems (sets of operations and related activities). Control of all systems will help ensure production of drugs that meet intended safety, identity, strength, quality, and purity characteristics.

According to 21 CFR 211, there are six systems that are covered in an FDA (Food and Drug Administration) surveillance inspection:
• Quality
• Facilities and equipment
• Materials
• Production
• Packaging and labeling
• Laboratory controls

Owen was fairly stressed out the last time his pharmaceutical lab received an FDA (Food and Drug Administration) surveillance inspection. Although they were approved, it was a very thorough, full inspection that covered four systems. Since then, their product and equipment have not changed. However, it is almost time for the next inspection, and Owen is considering the type of inspection that will be required.

Owen anticipates it will most likely be an abbreviated inspection because _______.

Answer explanation:
There are two surveillance inspection options: full and abbreviated.

A full inspection covers the quality system plus three other systems. It is required during an initial inspection or when there has been a history of noncompliance. It is also used when there are significant changes such as new technologies, equipment, or facilities.

An abbreviated inspection is meant to provide an efficient update evaluation of an organization’s Good Manufacturing Practices (GMP) compliance. This is usually conducted when:
• An organization has a record of satisfactory GMP compliance
• There are no significant recalls, product defects, or field alert incidents
• The manufacturing profile has not changed substantially within the previous two years

Last quarter, TCM Global Laboratories had to recall 100,000 units of their blood pressure regulation medicines due to a manufacturing error. All of the units were recovered before they were used by customers.

Due to this error, the FDA will most likely conduct a _________ inspection.

Answer explanation:
For-cause or directed inspections are used for anything other than pre-approval, post-approval, or routine surveillance inspections. For example, they are used when there is a need to investigate a specific problem that has come to the FDA’s (Food and Drug Administration) attention, such as TCM Global Laboratory’s product recall. For-cause or directed inspections are also used if there has been an NDA (New Drug Application) Field Alert report or an adverse event cluster.

Louise will conduct a full surveillance inspection at a pharmaceutical laboratory in two weeks. She must gather and coordinate a team to conduct the inspection because there is a lot of work to do and various specialties are required to address the multiple systems under review.

Which of the following specialties are often included in an FDA inspection team?

Answer explanation:
Section 704(a) of the FD&C (Federal Food, Drug, and Cosmetic) Act provides authority for the FDA to conduct inspections “upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge.”

Louise knows she must be reasonable in her time, limits, and manner of the objective inspection. To meet this standard, she will work with a team of experts in other specialty areas such as chemistry, microbiology, process/facility, and formulation.

Miguel is creating a plan for a directed inspection of Tobias Laboratories next week. As part of his due diligence, he is viewing documentation from which of the following sources?

Answer explanation:
Miguel’s inspection plan should be based on the following information:
• Previous Establishment Inspection Reports (EIRs)
• Previous FDA Form 483 observations and their related responses, warning letters, and/or related firm commitments
• The company’s website including product literature, products manufactured, and recent press releases
• Consumer complaints and recalls since the last inspection

Lakshmi is meeting Clint, the lead FDA inspector, on the morning of the first day of inspections at LG Manufacturing. As the agent in charge, Lakshmi wants to ensure that Clint’s documentation is in order.

Which of the following is Lakshmi permitted to do?

Answer explanation:
Clint is required by law to show his credentials upon starting an inspection to the top management official such as owner, operator, or agent in charge. Management may examine the investigators’ credentials and record the name(s) and phone number(s). However, credentials are not to be copied in any manner.

FDA inspections tend to be multi-day processes. At the end of each day, the lead inspector will typically:

Answer explanation:
On-site FDA inspections follow a standardized process in which the lead investigator will:
1. Issue a notice of inspection
2. Display credentials, state the purpose of inspection, and provide a general agenda
3. Tour the facility
4. Get into the details of the inspection
5. Hold a daily wrap-up meeting

Melissa, a senior manager at Ethan Pharmaceuticals, is having her monthly meeting with her mentor, Santiago. She was promoted to her new role less than three months ago and has questions about an upcoming FDA surveillance inspection (she has never been responsible for overseeing one). She asks Santiago about common violations that she should be aware of so she can address them before they become a problem.

Which of the following are common Good Manufacturing Practice (GMP) violations that Santiago could reference?

Answer explanation:
During an FDA inspection, inspectors are verifying that manufacturers like Ethan Pharmaceuticals are operating in a sufficient state of control by reference to the Good Manufacturing Practice (GMP) regulations and policies. If that is not found to be the case, inspectors must document accordingly to support the necessary action.

Common GMP violations include:
• Poorly trained employees
• Poorly maintained or contaminated equipment and facilities
• Lack of process control
• Failure to conduct investigations and resolve any discrepancies, failures, deviations, or complaints

Veronica is meeting with her team of FDA inspectors to prepare for an inspection at JLP Global the following day. Her team will focus on identifying any data integrity issues.

Veronica states that a big red flag indicating underlying problems is when activities are not recorded _________.

Answer explanation:
Investigators look for documentation and data integrity issues during their inspections. Some of the issues Veronica’s team will look out for include:
• Activities not being recorded contemporaneously
• Fabricating data to create acceptable test results
• Discarding data without appropriate documentation
• Data that looks too good to be true
• Lack of raw data (i.e., sample weights, sample solution prep)

Her team will ask those in charge at JLP Global to review documentation of past events as well as scientific evidence to support JLP Global’s conclusions.

When an inspection ends, it is generally classified into one of three categories:
• No Action Indicated
• Voluntary Action Indicated
• ________ Action Indicated

Answer explanation:
The three categories of inspections are:
• NAI- No Action Indicated
• VAI- Voluntary Action Indicated
• OAI- Official Action Indicated

The inspection report must be completed and provided to the organization that was inspected in a timely manner and incorporate all inspectional findings from each team member.

FDA (Food and Drug Administration) Inspection report conclusions can include which of the following?

Answer explanation:
The FDA’s (Food and Drug Administration) Field Medical Directive 86 (FMD-86) outlines that the conclusions and decisions of an inspection report can include:
• Voluntary actions
• Advisory actions (i.e., warning letters, untitled letters)
• Legal sanctions (i.e., seizure, injunction, prosecution)
• Recognition of positive behaviors

For more information, check out the FDA Field Management Directives:
http://www.fda.gov/downloads/ICECI/Inspections/FieldManagementDirectives/UCM382035.pdf

Kendra’s team just passed their Pre-Approval Inspection (PAI). She explains that in a few months, they will undergo their Post-Approval Inspection.
To ensure another successful FDA (Food and Drug Administration) inspection, Kendra and her team must all do their part, including:

Answer explanation:
To be prepared for an FDA (Food and Drug Administration) inspection, it is recommended to do the following:
• Know and comply with FDA regulations and policies
• Always follow SOPs (Standard Operating Procedures)
• Ask the investigator for clarification if you don’t understand or agree with an observation
• Be proactive and have a good attitude
• Display a willingness to correct problems, but do not promise to make a correction if you do not agree with it or are not sure that you will be able to follow through

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