TIPS FOR FIRMS RESPONDING TO FDA INSPECTIONS
A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer says.
Singer also says firms should be aware it is not uncommon for a second FDA investigator to find problems a previous inspector did not.
Devicemakers can wind up scrambling for help when they receive conflicting inspection findings from the FDA. Aaron Sorensen, president and CEO of Restorative Health, a company that found itself in this situation, said when he turned to the FDA for clarification he was simply told, "Go to the website."
If a company representative feels an FDA official has been unfair, "that person should talk to the person's supervisor," Singer said. "If that doesn't work, they can go the FDA ombudsman." If there is a pattern of inconsistent inspection reports in a certain FDA district, firms should go to their trade association and have the trade association report it to the FDA, Singer said.