FDA issued a Warning Letter to Contract Testing Laboratory in Uruguay following Data Integrity Violations

The FDA issued a Warning Letter on April 30, 2024, to a Montevideo-based contract testing lab following a November 20-22, 2023 inspection. Violations of Current Good Manufacturing Practice (CGMP) regulations were found, mainly in data integrity and documentation. Issues included  unreviewed out-of-specification results, incomplete records, and inadequate controls over data.

The company's response to a prior Form FDA 483 was deemed insufficient by the FDA. Observations included incomplete records, insufficient controls over data review, and lack of computer system controls, leading to data deletion.

 Requested actions include a comprehensive investigation of data inaccuracies, a detailed corrective action plan, and engaging a consultant for annual audits over two years.

 Non-compliance with CGMP standards may impact drug quality, safety, and efficacy. Grupo Quimico SRL has 15 working days to respond with a detailed plan. The complete Warning Letter is available on the FDA website.