Consolidated Chemical, Inc – FDA 483, Aug 2, 2019

This FDA Form 483 was issued to Consolidated Chemical, Inc. dba Care-Tech Laboratories, Inc. in Saint Louis, MO, following an inspection of their OTC human drug manufacturing facility. The inspection revealed significant deficiencies across multiple areas, including inadequate cleaning procedures, lack of scientific justification for OOS events, unmaintained facilities, improper storage conditions, and failures in quality control and stability testing programs. These issues indicate a broad lack of control over manufacturing processes and quality systems, posing potential risks to drug product quality and patient safety.