Q: I’m preparing a plan for what to do when an inspector shows up at our site for our next FDA inspection, including who will be the contact person, what information to give the inspector at the start of the inspection, what notes to keep during the inspection, etc.
I’d appreciate your feedback on a few details, because I’m not sure they are up-to-date for the latest FDA inspection protocols, such as:
- We will record the inspector’s ID. I have an older document that says the inspector will have a badge. Is there an FDA employee number or badge number we should record in addition to getting his/her business card?
- Is FDA Form 484 still used to document samples collected by the inspector?
- Are you aware of any current guidance from the Agency itself that helps manufacturers prepare for an FDA inspection?
A: Let’s take your questions in order:
- It’s a good idea to record the inspector’s ID. The actual badge has the employee number on it, and so do the inspector’s credentials.
- Yes, inspectors still use Form 484 if they take a physical sample. If they simply collect records (known as a documentary sample), they will not provide a receipt for samples. For medical device manufacturers, the most common sample is a documentary sample. Physical samples are more common for drug and food producers.
- The Agency doesn’t publish guidance on how to prepare for an FDA inspection. However, if you’re a medical device manufacturer, you should read FDA’s QSIT (Quality System Inspection Technique) Guide to help you anticipate what FDA will ask for during an inspection. In addition, the FDA Compliance Program Guidance Manual for the Inspection of Medical Device Manufacturers gives specifics on inspections and enforcement under 21 CFR Parts 820, 803, and 806.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Chapter 5 of FDA’s Investigations Operations Manual (IOM) describes the overall conduct of inspections.[/pullquote]
Drug makers should review the FDA Compliance Program Guidance Manual for Drug Manufacturing Inspections.
For all FDA-regulated industries, Chapter 5 of FDA’s Investigations Operations Manual (IOM) describes the overall conduct of FDA inspections. The IOM is the primary source of FDA policy and procedures for field investigators and inspectors and is considered “the bible” for FDA inspections. It’s updated annually by FDA, usually in the late spring.
The latest versions of all these FDA documents are available for free download from the Compliance Resource Library on EduQuest’s website.
Lastly, you might want to read the EduQuest Compliance Advisory I wrote on “Using FDA’s Own Playbook to Prepare for Your Next Audit”, which is available for purchase from Amazon’s Kindle Store. This Advisory is designed to help you use FDA’s IOM to assess your facility’s readiness for its next FDA inspection.
Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and as the co-editor of FDA’s Investigations Operations Manual). Denise also is the lead instructor for EduQuest’s The CAPA Clinic: Effective CAPA Systems, Failure Investigations and Complaint Management training class.