FDA Warns Florida OTC Maker for Testing, Water Quality

The FDA hit a Rockledge, Florida over-the-counter drugmaker with a warning letter over failures related to testing, quality unit oversight and water quality monitoring.

The company, Cross Brands Contract Filling, manufactures OTC sunscreens and contract manufactures OTC products containing topical salicylic acid. In a June 6-10, 2019 inspection, the agency found that it didn’t test drug product components, relying instead on the certificates of analyses it received from raw material vendors.

“You are required to verify the identity of each component used in the manufacture of your drug products,” the agency said, adding that the firm must test each component to ensure they meet strength, quality and purity specifications unless the supplier and their test results have been qualified and validated.