FDA WARNING_LETTER - MD Pharmaceutical Supply, LLC - May 09, 2022

The FDA inspected MD Pharmaceutical Supply, LLC's drug repackaging and relabeling facility in Hanover, PA, from April 25 to May 9, 2022, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate investigation of complaints and discrepancies:** The firm redistributed phentolamine mesylate API after a "quality issues" return without adequate investigation, and failed to investigate disparate expiration dates on a Certificate of Analysis (COA) for aminocaproic acid API. The firm's response was inadequate, lacking a retrospective review and storage condition verification for returned goods. 2. **Failure to maintain appropriate API storage conditions:** Temperature probes were non-operational, and humidity was not monitored. The firm could not provide records demonstrating compliance with manufacturers' storage requirements. Their corrective action plan was insufficient, lacking details on probe placement, responsible personnel, and data control. 3. **Failure to perform repackaging and relabeling under appropriate CGMP:** Operations were conducted in an uncontrolled environment without adequate controls for mix-ups or cross-contamination, specifically for highly potent Dasatinib monohydrate API and immunosuppressive sirolimus API. The firm's commitment to cease these operations was deemed inadequate without a retrospective assessment of potential mix-ups or cross-contamination.

The FDA strongly recommends engaging a CGMP consultant. The firm'