FDA 483 - Specialty Process Labs LLC - January 26, 2024

During an FDA inspection conducted from January 18-26, 2024, Specialty Process Labs LLC, an Active Pharmaceutical Ingredient (API) manufacturer, received a Form FDA 483 detailing significant deviations from regulatory expectations. The inspection highlighted critical shortcomings across multiple operational areas, indicative of a failure to adhere to Current Good Manufacturing Practices.

Key violations included inadequate validation of manufacturing processes for thyroid API, encompassing incomplete validation studies at both current and previous facilities, and a lack of proper recording for critical control parameters. The firm also failed to investigate numerous out-of-specification results for product strength and loss on drying identified during stability studies. Furthermore, cleaning validation procedures were deficient, neglecting microbiological and residual detergent testing, with visible residues observed on "Ready to Use" equipment.

Significant data integrity concerns were raised, as electronic batch records and analytical data were susceptible to unauthorized modification or deletion, and essential audit trails were not established. The quality unit demonstrated failures in overseeing corrective and preventive actions (CAPAs), with multiple investigations remaining unaddressed for extended periods and a lack of established specifications for an identified impurity. Finally, microbiological testing practices were found deficient, involving unvalidated methods, absence of media growth promotion, and the presence of expired media. Specialty Process Labs LLC is required to respond to these observations with a detailed plan of corrective actions.