FDA 483 - Swabplus, L.P. - August 01, 2023

During an FDA inspection conducted from July 25 to August 1, 2023, at Swabplus, L.P., a contract repacker located in Rancho Cucamonga, CA, several critical observations were made. The inspection revealed significant compliance issues under the regulatory framework governing drug manufacturing practices.

Key violations included the failure to adhere to procedures preventing objectionable microorganisms in non-sterile drug products. Specifically, the firm did not perform required sanitization of its purified water system as per its own standard operating procedures (SOP0810.1). This was noted as a repeat observation, indicating a recurring compliance issue.

Additionally, the firm lacked appropriate controls over computer systems to ensure that changes to production and control records were made only by authorized personnel. The audit trails for analytical instruments like HPLC and FT-IR were not reviewed comprehensively, potentially allowing unauthorized retesting of samples.

Another significant issue was the labeling of drug products with expiration dates that exceeded those supported by stability data, as evidenced by discrepancies in the expiration dates of Dr. Piercing’s Aftercare products.

Further, the quality control unit's responsibilities and procedures were neither adequately documented nor followed. This included the absence of active SOPs for handling deviations from GMP laboratory procedures and inadequate document control measures, leading to potential unauthorized modifications.

The FDA requires Swabplus, L.P. to address these violations by implementing corrective actions, including revising SOPs, enhancing document control, and ensuring comprehensive review and authorization processes for all quality-related records. Failure to comply may result in further regulatory actions.