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# CGMP Deviations at Marcus Research Laboratory
- URL: https://www.fdaweb.com/cgmp-deviations-at-marcus-research-laboratory/
- Published: 2021-10-19T12:00:00.000Z
- Updated: 2026-09-14T17:19:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150397

An FDA 5/3-5/14 inspection at Marcus Research Laboratory, a St. Louis, MO, drug manufacturing facility, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 9/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/marcus-research-laboratory-inc-615153-09302021?ref=fdaweb.com) says specific deviations were: 

- failing to have the procedures and processes necessary to ensure the APIs manufactured at the facility meet established specifications for quality and purity; and
- failing to ensure that equipment surfaces in contact with raw materials, intermediates, and APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications.

The letter says the agency strongly recommends that Marcus engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The company was told to correct any deviations promptly and respond with a list of specific actions it has taken to address any deviations and prevent their recurrence, with a schedule for completing the actions.