FDA 483 - Potter's House Apothecary, Inc. - September 16, 2020

During an FDA inspection conducted from September 2 to September 16, 2020, Potter's House Apothecary, Inc., a producer of sterile and non-sterile drugs, received a Form 483 detailing significant observations. The inspection revealed several deficiencies related to manufacturing controls and aseptic processing. Key issues included inadequate cleaning and disinfection systems within aseptic processing areas, specifically noting a reddish-purple splatter in an ISO 5 Laminar Airflow Workbench after cleaning, indefinitely stored sterile wipes, and cracks in the LAFW panels. Personnel were also observed contacting product-contact surfaces, such as an unstoppered vial, with gloved hands during aseptic operations, posing a contamination risk. Furthermore, the certification of ISO 5 classified areas for unidirectional airflow was found to be insufficient, lacking dynamic condition verification, adequate smoke studies, inclusion of critical equipment, and observation of technician interaction. Lastly, media fills, designed to simulate production, did not adequately represent worst-case scenarios, failing to include the filling of prefilled syringes, a routine sterile production process. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, require the company to promptly address the identified conditions and practices to ensure the safety, quality, and integrity of its drug products. Potter's House Apothecary, Inc. is expected to implement robust corrective actions to resolve these compliance issues.