Part I of this series summarizing the May 28 Govzilla webinar,  “Guess Who’s Knocking at Your Door: Assuring Inspection Success!”, covered Steven Niedelman’s remarks on the legal and regulatory framework for FDA inspections.

The following looks at the types of inspections FDA conduct plus what the agency can inspect and what it cannot inspect. 

Types of FDA Inspections

FDA conducts three main types of inspections. Preapproval inspections generally support New Drug Applications (NDAs), Premarket Approvals (PMAs), and licensing agreements. For-cause inspections are conducted in response to information the agency considers a potential public health risk. These include:

  • Increased adverse events
  • Significant adverse event
  • Possible catastrophic Medical Device Report (MDR) 
  • Escalating numbers of reports
  • Circulating issues that give cause for concern
  • Increases in recalls or Class 1 recalls
  • Significant increase in customer complaints
  • Whistleblower reports

“The agency also conducts bioresearch monitoring inspections of clinical studies to assure that protocols are being followed,” Niedelman said. “These are conducted at the investigative sites as well as the sponsor sites. It also makes sure that documents are being maintained contemporaneously and that there is no product diversion.”

Get Started with Redica for Free

Factors That Increase Inspection Chances

Several factors can increase the likelihood of an FDA inspection. U.S. Congressional legislation now mandates FDA use risk-based factors when choosing to inspect a site. This replaces the previous two-year inspection requirement. 

Niedelman listed a number of factors FDA looks at when determining to conduct an inspection (Figure 1).

Figure 1 Risk Factors for Inspection

“Prior inspectional history is important,” he said. “If you have had poor inspections in the past, that is going to be a continuing, annoying concern at FDA that requires them to come and do follow-up inspections. That would include follow-ups to warning letters, untitled letters, etc.”

Further, FDA is more likely to inspect a site which has a history of not correcting issues cited by the agency.

Additionally, “if you have significantly challenging products to manufacture or very high risk products or new and novel technologies, FDA is going to want to come in and inspect more frequently at your firm than at one that makes a more sedentary product, one that is not as challenging to manufacture or might not be as clinically significant as one of your competitors,” Niedelman said. “For example, if you are manufacturing a sterile product versus a non-sterile product. Even within sterile products, aseptic processing is a more challenging process than some other types of sterilization.”

If you have had poor inspections in the past, that is going to be a continuing, annoying concern at FDA

So, What Can FDA Inspect?

Niedelman outlined a number of areas/items FDA can inspect (Figure 2).

Figure 2 What Can FDA Inspect

Figure 2 What FDA Can Inspect

“FDA can inspect vehicles used to hold or transport pharmaceuticals or medical devices,” he said. “FDA has seized trailers full of products. There are firms where FDA would come in the front door and the violative product would go out the back door or be stored in tractor trailers and then sealed. FDA would become aware of it. And FDA would freeze that trailer on site. There are many times that the FDA has seized trailers in transport. They do have access to all your transport vehicles, including rental ones.”

FDA investigators can also look at raw materials and their components. With manufacturing equipment, they can look at any piece to ensure it has been installed properly as part of the validation process.

Any finished or unfinished pharmaceuticals are fair game,” Niedelman said. “The same goes for medical devices, along with any containers used to manufacture, store, or distribute pharmaceuticals.”

Source containers for medical devices and labeling can also be inspected, although investigators generally do not comment on labeling. 

There are many times that FDA has seized trailers in transport

Records that can be inspected include details on the movement of products in the supply chain, all records pertaining to adverse events, recalls, MDRs, etc., and all records required by CGMP or the quality system, including drug master files, device master records, batch records, device history records, product reviews, complaint files. 

He stressed that it is important to document what inspectors looked at to ensure adequate follow-up in case questions arise after the inspection.

What Is FDA Prohibited from Inspecting?

While FDA investigators can inspect many things at a site, there are a number of things they cannot ask to review (Figure 3).

“FDA investigators are trained to ask for the sky, the moon, and the stars,” Niedelman said. “It is up to you to be able to know what they are and are not entitled to during an inspection.” 

Figure 3 What FDA Cannot Inspect

 Figure 3 What FDA Cannot Inspect

For example, the FDA is not entitled to review a firm’s financial data, such as profit margins. 

“FDA really does not care about dollars,” Niedelman said. “That is not an argument that holds water. Even when a recall is taking place, you will not necessarily get the ear of FDA if you say, ‘well, these products cost a lot of money, it is going to put us out of business.’ For FDA, it is all about the public health.”

Most importantly, investigators are not entitled to records or reports resulting from internal audits, management reviews, or supplier audits as these are outside their scope. FDA wants companies to feel they have the freedom to identify and correct problems on their own. But investigators can examine written procedures established for internal audits, management reviews, and supplier audits, even requesting written certification that these activities have been performed and documented. Any CAPAs opened as a result of these activities are also fair game. 

Get Started with Redica for Free



Human Factors – Compliance and Applications

June webinar

Presented by Alison Sathe, Founder, Regulatory Mark & Valerie Fenster, Director of Insights and  Human Factors, Kaleidoscope Innovation 

June 29, 1:30 p.m. EST

What you will learn:

  • Human factors strategies from simple drug products to complex surgical devices
  • Primary and secondary labeling development and evaluation for usability
  • Human factors activities from product development to post-market
  • International strategies: expectations for human factors in regulatory submissions in international markets

Panel Discussion – Remote Audits

Panel Discussion opt in image

Featuring Panelists:
—Barbara W. Unger, Unger Consulting, Inc.
—Jerry Chapman, Redica Systems
—Stephanie Gaulding, Pharmatech Associates

Who Will Benefit?
This session will be valuable to GMP quality, regulatory, compliance, and management personnel in FDA-regulated industries who want to have a conversation on remote audits and get to know what is going on in the industry.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore observations and trends. 

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to run your custom report.

Redica Systems Enforcement Analytics

Get help choosing the right CRO.

Enter your email address and someone will contact you shortly to customize your insights.

Redica Systems Enforcement Analytics

Compare two companies of your choice.

Enter your email address and someone will contact you shortly to customize your report.

Download the Special Report

Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

In this summary we identify:

  • Trend analysis of FDA inspections through mid-2020
  • Strategies for preparing and hosting virtual inspections
  • New technologies to support remote inspections

Download the Special Report

CDMO Comparison opt-in

In this summary we identify:

FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

Top FDA 483 observations

Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

  • How to use the Leadership SOS Model to transform quality culture
  • How to strengthen quality systems to eliminate human error
  • How to generate ideas on how to set your organization up for success for shareholders, FDA, and staff
Redica Systems Enforcement Analytics

Prepare for inspections of Clinical Investigator sites.

Enter your email address and someone will contact you shortly to provide more Clinical Investigator data about your sites.

Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Get instant access to the webinar video and slides.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
    Recent enforcement trends involving the Quality Unit
    Impact of the COVID-19 pandemic

Download the Special Report

APAC ad

In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Redica Systems Enforcement Analytics

Prepare for your next inspection.

Enter your email address and someone will contact you shortly to explore enforcement trends. 

Redica Systems Enforcement Analytics

Monitor compliance at your Clinical Investigator sites.

Enter your email address and someone will contact you shortly to get you started.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Let us know who you are and we’ll be in touch to answer all of your questions and get you started.

Redica Systems Enforcement Analytics

Upgrade your CDMO monitoring strategy.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Keep up with the latest Regulatory Developments on Clinical Trials

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save your team valuable time when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Save time and Resources when using External Monitoring.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Get immediate access to the news that matters to your sites.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

See how we can help you eliminate yet another spreadsheet.

Enter your email address and someone will contact you shortly. 

Redica Systems Enforcement Analytics

Stay ahead of changing regulations.

Enter your email address and someone will contact you shortly to get the data and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your CDMO management strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Redica Systems Enforcement Analytics

Compare the enforcement history of your CDMOs.

Enter your email address and someone will contact you shortly to customize your report.

Experience the Power of Redica Systems

Redica Systems Enforcement Analytics

Sign up for your FREE account today and get instant access to Enforcement Analytics.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need.

Redica Systems Enforcement Analytics

Upgrade your inspection strategy.

Enter your email address and someone will contact you shortly to get the reports and analysis you need to prepare for your next inspection.

Experience the Power of Redica Systems

Complete the form and one of our experts will reach out to you to schedule a demo and answer questions about our subscription options.

INDEX INFORMATION  Redica consolidates regulatory data in real-time on the single largest database for quality, safety, and compliance intelligence.

STRENGTHEN DATASETS Redica machine intelligence algorithms identify and triage risk signals to derive meaning from vast amounts of private and public data.

ANALYZE & INTERPRET PATTERNS Redica instantly models the customer-specific regulatory risks, trends, and opportunities that stand to fundamentally change compliance operations.

Redica Systems Enforcement Analytics

Evaluate Your CDMOs

Enter your email address and someone will contact you shortly to customize your report.

Redica Systems Enforcement Analytics

Compare the inspection history of your CDMO sites.

Enter your email address and someone will contact you shortly to customize your report.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.