FDA Warning Letter states about observation of particulates in repackaged drug components

In January 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Glicerinas Industriales, S.A. de C.V., a Mexican company, following a May 2023 inspection.

The letter highlighted several violations of Current Good Manufacturing Practice (CGMP) regulations for active pharmaceutical ingredients (APIs), including failure to conduct identity testing on incoming materials and inadequate investigation of deviations from procedures.

The FDA found that the company failed to properly investigate contamination observed in packaged drugs, including insects, hair, and fibers, without rejecting affected batches or identifying the root cause adequately. The company also neglected to follow internal procedures for Corrective and Preventive Actions (CAPA) and documentation of contamination, risking customer safety.

The FDA recommended consulting a CGMP expert and placed the company on Import Alert, potentially refusing new applications until compliance is achieved. The APIC guidance on handling particles in APIs could assist in remediation efforts.

For details, refer to the Warning Letter to Glicerinas Industriales, S.A. de C.V. issued by the FDA.