Last year FDA inspectors were noting a number of problems with a plant in China when the facility's manager suddenly said the inspection was over and sent them packing. The FDA's response was that the plant was not meeting its GMP standards and put its over-the-counter products on import alert. Now the FDA wants to formalize when an inspection can be legitimately delayed and what the fallout for manufacturers will be if its inspectors are kept from doing their jobs.
The FDA in draft guidance says that it often schedules inspections with drugmakers to give them time to prepare and have records in order when inspectors arrive. It's also willing to delay or reschedule an inspection when there are good reasons to, like issues with weather, security problems in a country, or a holiday.
But if a plant delays or refuses inspectors without a good reason, the agency can rule that the plant's products are "adulterated" and ban them from import into the U.S. The guidance says it can take that action if its inspectors are restricted in a number of ways. Of course, a plant can't simply refuse to schedule an inspection. Once inside a plant, inspectors need to be able to copy records and take samples and photographs that provide a record of conditions. If plant managers keep them from doing any of these things or prevent them from seeing manufacturing processes, the FDA says it is within its rights to stop the plant's products from being allowed into the country. The law even allows the FDA to impose "criminal penalties" in some cases, the FDA said in the guidance.
Any company that has dealt with the FDA or other established regulatory agencies around the world for any time knows the drill and would never try to prevent inspectors from seeing what they want and review whatever records they need. Many drugmakers will even bring to the attention of the FDA issues they are aware of and are trying to address. But the FDA is expanding its foreign inspections in places like China, and some of those operations are not used to the rigors of an FDA inspection. Once the new rule is established, there will be no doubt about what is expected of them. The guidance was posted July 12 and the FDA is seeking comments for 60 days from that date.
- read the draft guidance