FDA 483 - Klocke of America, Inc. - March 30, 2022

Klocke of America, Inc., an OTC Drug Repacker in Fort Myers, FL, was cited for four observations during an FDA inspection. The findings indicate significant deficiencies in the firm's quality control unit procedures, including lack of written procedures, improper logbook management, and deficient procedure approval processes. Additionally, the facility exhibited structural issues, equipment cleaning validation was inadequate, and computer systems for balance weights lacked validation.