FDA 483 - Eosera, Inc. - January 17, 2020

Konec, Inc., an OTC manufacturer in Fort Worth, TX, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in process validation, quality control procedures for rejecting out-of-specification products and components, unsupported expiration dates, and inadequate microbiological testing of raw materials. These issues indicate a lack of robust quality systems to ensure product quality and safety.