FDA's New Warning Letter Practices
(Oct. 28, 2010). In August of 2009 US Food and Drug Administration Commissioner Dr. Margaret Hamburg announced a new policy on Warning Letters. She said that FDA may move immediately, without issuing a formal warning letter, on "significant health concerns or egregious violations" that pose "an immediate threat to health" and when informing the public and removing a product from the market is necessary to prevent harm to people.
Industry has been waiting to see how this new policy will be implemented. We found out more at MichBio Expo 2010. Steven Barber, Director of the Compliance Branch at the Detroit District Office said that the Agency has five new goals:
- Post inspection deadlines.
- Expedite issuance of the Warning Letter.
- Increase coordination with partners, such as state agencies.
- Prioritize follow up activities.
- Swift and aggressive action.
The important message for manufacturers comes out of the first goal. Within 15 days of an inspection a decision must be made whether to initiate action on the company. In situations which in the past would have resulted in a Warning Letter and nothing more, the District office must now explain why the product was NOT seized. The rationale being that if the facility is violating Good Manufacturing Practices to the extent that a Warning Letter is warranted, the public's health is in danger.
While the regulations do not require you to respond to a 483, it has always been a good practice. The importance of timely communication with the Agency is now even more critical. If you are issued a 483 after an inspection, you should send your response immediately. It’s also a good idea to arrange a meeting with the agency to explain your response.
