FDA 483 - API Solutions Inc. - May 27, 2026

An FDA inspection of API Solutions Inc., a re-labeler in Daphne, AL, revealed significant deficiencies in quality control and production processes. Observations included a failure to conduct temperature mapping studies and maintain records for drug product storage areas, a Quality Unit oversight in detecting missing signatures on batch records, and inadequate GMP training for employees. These issues indicate a lack of adherence to established procedures and CGMP requirements.