FDA Issues Warning Letter to Darmerica, LLC for Supplier Oversight Failures

In 2026, the FDA issued a Warning Letter to Darmerica, LLC, a Florida-based distributor of active pharmaceutical ingredients (APIs), citing serious deficiencies in its supplier qualification and quality oversight programs.

Key Findings:

• Supplier Qualification Gaps: The firm failed to verify conflicting information in vendor surveys regarding regulatory inspections before approving or re-qualifying suppliers. One supplier falsely claimed FDA inspections, which the firm did not investigate. Required stability testing and reserve samples were missing, yet the supplier continued to be qualified.
• Complaint Management Failures: Customer complaints about black particles in an API lot were not fully investigated. The Quality Unit (QU) did not contact all affected customers, assess other lots, or critically evaluate the supplier’s “technically unavoidable particles” explanation. Manual removal of particles by customers was accepted, violating CGMP standards.
• Supplier Reassessment and Recall Oversight: The QU failed to link complaint management to supplier re-qualification and continued distributing affected lots. Recall communications to customers were undocumented, showing inadequate oversight.

The FDA concluded that these issues reflect systemic failures in supplier oversight, quality management, and CGMP compliance.

21-01-2026