FDA 483 - Cantrell Drug Company - November 04, 2013

This FDA Form 483 details multiple observations from an inspection, indicating significant deficiencies in the facility's manufacturing and quality control systems for drug products, particularly those purporting to be sterile.

Key observations include: * **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established. * **Personnel & Environment:** Personnel clothing is inappropriate for duties. Aseptic processing areas lack adequate environmental monitoring and systems for cleaning/disinfecting equipment. * **Laboratory Controls:** Laboratory controls do not include scientifically sound test procedures to assure drug product identity, strength, quality, and purity. * **Stability Testing:** No written program exists to assess drug product stability characteristics. * **Complaint Handling:** Procedures for handling written and oral complaints are deficiently written or followed. * **Containers & Closures:** Drug product containers and closures are not clean or suitable for intended use. Approved containers/closures are not retested for identity, strength, quality, and purity after adverse exposure. * **Component Identity:** Each drug product component's identity is not verified by at least one test, including specific identity tests where applicable. * **Facility Construction:** Buildings are not suitably constructed to facilitate cleaning, maintenance, and proper operations. * **Employee Training:** Employees lack specific training for their operational functions.

These observations indicate a broad range of non-compliance issues impacting product quality, safety, and regulatory