FDA EIR - Winder Laboratories, LLC - March 13, 2020

An FDA inspection of Winder Laboratories, LLC, conducted from March 9-13, 2020, identified significant deficiencies in the company's quality control systems and adherence to current Good Manufacturing Practices (cGMP), referencing 21 CFR Part 211. Major violations included a failure to adequately test the purified water system for objectionable microorganisms and total yeast and mold counts (TYMC), as required by 21 CFR 211.84(d)(6). Management exhibited a lack of awareness regarding these essential testing requirements and the identification of objectionable organisms. The company also demonstrated a widespread failure to thoroughly investigate unexplained discrepancies, out-of-specification (OOS), and out-of-trend (OOT) results for water quality, as mandated by 21 CFR 211.192. These investigations were often incomplete, lacking organism identification and sufficient evidence, even while products were manufactured using compromised water. Furthermore, the inspection identified inadequate handling of customer complaints, per 21 CFR 211.198(b)(3). Complaint records frequently lacked documentation of investigation decisions, thoroughness, and timely follow-up, extending to incomplete batch record reviews and broader product impact assessments. Other issues included deficient water system and equipment cleaning validations, untimely annual product reviews, and a failure to attach raw data to investigations. Required actions include implementing comprehensive microbial testing for the water system, conducting robust investigations into all quality deviations, ensuring timely and thorough complaint handling, and improving validation protocols and documentation to comply with regulatory standards. Management acknowledged these issues and indicated plans to engage consultants and update procedures.