FDA WARNING_LETTER - Grupo Quimico SRL - November 22, 2023

The FDA inspected Grupo Quimico SRL, a contract testing laboratory in Montevideo, Uruguay, from November 20-22, 2023, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the drugs tested by the firm are considered adulterated under section 501(a)(2)(B) of the FD&C Act. The firm's December 8, 2023, response to the FDA Form 483 was deemed inadequate due to insufficient supporting documentation and evidence of corrective actions.

Key violations include the failure to ensure complete laboratory records, specifically regarding unreported Out-of-Specification (OOS) results and unindicated manual sample integration (21 CFR 211.194(a)). The firm also failed to establish adequate laboratory controls, lacking procedures for electronic data review, manual integration, and proper system suitability criteria (21 CFR 211.160(b)). Furthermore, there was a failure to exercise appropriate controls over computer systems, allowing data deletion and operating with disabled audit trails on HPLC systems (21 CFR 211.68(b)). These deficiencies raise serious data integrity concerns, questioning the authenticity and reliability of analytical data.

FDA strongly recommends retaining an independent third-party consultant for data integrity remediation. The firm must provide a detailed investigation protocol, assess the extent of data integrity deficiencies, conduct a comprehensive retrospective evaluation, and submit a detailed corrective action plan within 15 working days. Failure to address these violations may result in FDA withholding approval of new applications and refusing admission of client products into the United States.