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