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

The FDA conducted an inspection of Swabplus, L.P., a contract repacker located in Rancho Cucamonga, CA, from July 25 to August 1, 2023. The inspection revealed several significant compliance issues. Key observations included the failure to sanitize the purified water system as per the company's Standard Operating Procedures (SOP), inadequate controls over computerized systems, and improper audit trail reviews for High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared (FT-IR) instruments. Additionally, the firm was found to label drug products with expiration dates exceeding those supported by stability data, and the responsibilities and procedures of the quality control unit were not fully documented or followed.

The regulatory framework requires adherence to Good Manufacturing Practices (GMP) to ensure product safety and efficacy. Swabplus, L.P. was found to have repeat violations, indicating a lack of corrective actions from previous inspections. The FDA requires the company to address these issues by implementing corrective measures, such as ensuring proper sanitization procedures, enhancing audit trail reviews, and establishing robust document control systems. The firm must also ensure that expiration dates are scientifically justified and that all quality control procedures are documented and adhered to. Failure to comply may result in further regulatory actions.