# FDA 483 - Marcus Research Laboratory, Inc. - December 06, 2019

Source: https://www.keypedia.com/records/483/marcus-research-laboratory-inc/a30d3fb2-0251-49bf-814d-28f806fb3a3d

> FDA 483 for Marcus Research Laboratory, Inc. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marcus Research Laboratory, Inc.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Marcus Research Laboratory, Inc., an API manufacturer in St. Louis, Missouri, revealed significant deficiencies across its operations. The firm failed to adhere to quality control procedures, including proper OOS investigations and document control, and lacked adequate process validation and stability testing methods. Additionally, the facility exhibited poor maintenance, labeling errors, and insufficient contamination prevention measures, indicating a broad failure to meet GMP standards.

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## Related Officers

- [Ana F. Sandee](https://www.keypedia.com/people/ana-f-sandee/2f5c053f-73d2-43e3-85a3-7565d73a9d29)
- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.keypedia.com/companies/marcus-research-laboratory-inc/6ed62b27-3200-4374-b004-ec4c541dc0d9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8