FDA 483 - Carma Laboratories, Inc. - November 14, 2023

An FDA inspection of Carma Laboratories, Inc. in Franklin, WI, a drug and cosmetic establishment, revealed significant deficiencies in quality control, training, facility sanitation, and data integrity. The firm failed to follow its own procedures for managing complaints, CAPAs, and nonconformances, and exhibited poor control over computer systems and document issuance. These issues indicate a lack of adherence to current Good Manufacturing Practices for their OTC lip balm and cold sore treatment products.