FDA 483 - W & C dba The Apothecary - June 17, 2016

An FDA inspection of W & C dba The Apothecary, a producer of sterile drug products in Sartell, MN, was conducted from June 6 to June 17, 2016. The resulting FDA Form 483 documented significant deficiencies indicating potential non-compliance with current Good Manufacturing Practices (CGMP).

Key violations included inadequate environmental monitoring in aseptic processing areas, such as a faulty HEPA filter not being replaced for six months and insufficient monitoring of air, surfaces, and personnel. The company's cleaning and disinfection procedures were also deficient, involving the use of non-sterile agents and incorrect contact times in critical areas. Furthermore, procedures to prevent microbiological contamination were not established or followed, evidenced by the absence of smoke studies and unvalidated sterilization processes for equipment and drug products.

Additional observations included the lack of a written program for stability testing, leading to unsupported beyond-use dates for products. Inadequate investigations were noted for significant deviations, such as microbial growth and temperature excursions for stored drug products. Critically, some drug products, like Papaverine/Phentolamine/Prostaglandin injectable, were released despite potency levels falling outside defined acceptance criteria. Finally, the firm lacked proper written and followed calibration procedures for essential instruments, including scales and thermometers.

To address these findings, W & C dba The Apothecary is required to promptly implement comprehensive corrective actions to ensure the quality, safety, and purity of its sterile drug products.