FDA 483 - Cantrell Drug Company - October 14, 2016

On October 14, 2016, the FDA issued a Form 483 to Cantrell Drug Company, an outsourcing facility located in Little Rock, AR, following an inspection conducted from September 14 to October 14, 2016. The inspection identified twelve observations related to deficiencies in their manufacturing and quality control processes.

Key observations include: - **Aseptic Processing Deficiencies:** Inadequate cleaning and disinfection systems for aseptic areas, including improper storage and use of cleaning solutions and sterile wipes. - **Microbiological Contamination Prevention:** Lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products. - **Environmental Monitoring:** Deficiencies in the system for monitoring environmental conditions in aseptic processing areas. - **Laboratory Control Deficiencies:** Test procedures for sterility and pyrogens are not written and followed. - **Stability Testing:** Absence of a written testing program to assess drug product stability. - **Product Release Testing:** Failure to conduct appropriate laboratory determinations of identity and strength for each active ingredient prior to drug product release. - **Air Supply:** Deficiencies in the aseptic processing area's air supply, specifically regarding HEPA filtration and positive pressure. - **Discrepancy Review:** Failure to thoroughly review unexplained discrepancies, even for distributed batches. - **Labeling Deficiencies:** Drug product labels from the outsourcing facility were found to be deficient. - **Deviation Management:** Devi