FDA Inspection delayed, denied or restricted for the Inspector - what happens?

Recommendation

2/3 May 2024

Process Validation - Live Online Training

What actually happens when you delay, deny, or restrict an FDA inspection for the inspector?

A new draft guidance from the Food and Drug Administration (FDA) describes exactly how the FDA deals with this issue. The "Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection" is 13 pages long, divided into the 6 chapters

• Introduction 
• Background 
• Delay of Inspections 
• Denial of Inspection 
• Limiting of Inspection 
• Refusal to permit Entry or Inspection

The guideline, when finalised, will replace a previous version from October 2014 "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection".

Interestingly, this draft applies the term "altered", which is normally only used for drugs, to medical devices as well. And this is exactly how the FDA also rates devices, based on a delayed, denied or limited inspection, as "adulterated". Examples of unfounded delays, denials and restrictions are included in the draft guidance. However, good reasons for a delay, denial or restriction that are acceptable to FDA are also provided. For example, the authority states that of course delays in inspections can occur. However, this must then be well justified by the pharmaceutical or medical device companies scheduled for inspection. An obstacle could be, for example, that a product is only manufactured very rarely and no production is scheduled during the planned inspection. 

Reasons why batch documentation might not be available during an inspection are also mentioned:

• The lack of an English translation. 
• The batch documentation is currently still used for production 
• Storage of the documentation off-site requires additional time to compile the documents 

Even acceptable reasons for refusing an inspection are mentioned, e.g.

• The absence of key personnel during unannounced inspections 
• Closure of production due to planned maintenance

Even a reference to a lack of validation of the gowning procedure of an FDA inspector wishing to enter a clean room justifies denying an inspector access.

Also explained are examples of photocopy restriction, both acceptable and unacceptable to FDA.

Conclusion: The draft guidance contains exciting examples of which aspects the FDA accepts and which aspects it does not accept in the case of a delayed, refused or restricted inspection. It is interesting that medical devices can also be designated as "adulterated" - and thus can no longer be placed on the market.

On the FDA website you can find the Draft Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.