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FDA Warning Letter Explorer
FDA warning letter · Drugs

MD Pharmaceutical Supply, LLC

Issued · Posted by FDA

FDA published a close-out letter on Apr 17, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to adequately investigate and document complaints or any unexplained discrepancies with the original API manufacturer.

Passage 2

Failure to perform holding of API under appropriate CGMP to avoid loss of API identity or purity.

Passage 3

Failure to perform repackaging and relabeling of API under appropriate CGMP to avoid mix-ups and potential cross-contamination.

Passage 4

Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any and deviations.