Proquimes S A Productos Quimicos Especializados S.A. – FDA Warning Letter, Apr 13, 2021

The FDA issued a Warning Letter to Proquimes S.A. Productos Quimico Especializados S.A. on April 5, 2021, following a review of records submitted in response to a Section 704(a)(4) request. The facility, an API manufacturer, was found to have significant deviations from current Good Manufacturing Practice (CGMP), rendering its drug products adulterated.

Key violations include: 1. **Failure to validate manufacturing processes:** The company distributed API to the U.S. without validating critical processes, specifically for (b)(4) USP API, indicating an inability to consistently produce API meeting quality attributes. 2. **Inadequate qualification of critical equipment:** Critical manufacturing equipment was not qualified, impacting batch-to-batch consistency. 3. **Failure to validate cleaning procedures:** Cleaning processes for shared API manufacturing equipment were not validated, posing a risk of cross-contamination. 4. **Failure to test incoming production material identity:** Incoming raw materials for API intended for the U.S. market were not adequately tested for identity due to "lack of resources."

The FDA requires a remediation plan for all U.S.-marketed API, including a data-driven program for process variability, a detailed validation program, a timeline for process performance qualification, and updated SOPs for cleaning validation. For equipment, a comprehensive evaluation and CAPA plan are required. For incoming materials, a review of the material system