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FDA Warning Letter Explorer
FDA warning letter · Drugs

Marcus Research Laboratory, Inc.

Issued · Posted by FDA

FDA published a close-out letter on Oct 4, 2024. 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 have the procedures and processes necessary to ensure the API manufactured at your facility meet established specifications for quality and purity.

Passage 2

Failure to ensure that equipment surfaces in contact with raw materials, intermediates and API do not alter the quality of the intermediates and API beyond the official or other established specifications.

Passage 3

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 deviations.