- The FDA has released final guidance outlining expectations for behavior during facility inspections. This guidance was issued in response to the fact that some companies have stymied FDA inspections by hiding certain things during inspections.
- Under Section 707 of the FDA Safety and Innovation Act, the FDA may deem a drug "adulterated' if it has been manufactured in a facility in which inspection was either denied or obscured in any way.
- In addition to outlining expectations for the behavior of manufacturers, the guidance states that FDA representatives will enter facilities in "a reasonable manner, within reasonable limits and at reasonable times."
The FDA is tackling the challenge of manufacturers who refuse or delay the entry of FDA inspectors. This new guidance is designed to make sure that those behaviors have consequences.
The finalized rules also offer detailed explanations of what constitutes a delay. For example, not allowing an inspector access to a part of the facility or not allowing them to speak with certain individuals is considered blocking access. Even failing to return phone calls is considered obfuscation. The FDA also has the right to take photographs, although the final guidance clarifies that companies can protest such photography if it would "adversely affect product quality."
In the last two weeks alone, the FDA has had to issue warning letters to two separate Chinese manufacturing facilities.