FDA Retracts Warning Letter to Devicemaker

The FDA has retracted a warning letter previously issued to medical device manufacturer Ophtec after finding that citations in the letter were “factually inaccurate,” Ophtec President Rick McCarley said.

This appears to be the first time the agency has retracted a warning letter, FDA spokeswoman Crystal Rice said. The FDA confirmed it retracted the warning letter and, according to Rice, the agency’s database “has no information on [any other] warning letters that have been rescinded. Furthermore, we have no recollection of any warning letters that have been rescinded.”

McCarley said the FDA called him July 9 to inform him of the retraction. The agency also sent a letter to his firm.