# FDA 483 - Marcus Research Laboratory, Inc. - July 20, 2021

Source: https://www.globalkeysolutions.net/records/483/marcus-research-laboratory-inc/cc55fc56-6dff-4040-88bc-f0fbc13b8a4d

> FDA 483 for Marcus Research Laboratory, Inc. on July 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marcus Research Laboratory, Inc.
- Inspection Date: 2021-07-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Marcus Research Laboratory, Inc. in Saint Louis, MO, a human and animal drug manufacturer, was cited for significant deficiencies in its quality system, including releasing API without ensuring quality after incidents, inadequate quality unit independence, and poor equipment maintenance. The inspection revealed issues with batch record completeness, lack of cleaning validation, improper container labeling, and insufficient GMP training for personnel. These observations indicate a systemic failure to adhere to good manufacturing practices for Povidone Iodine API.

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## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Matthew M. Schuckmann](https://www.globalkeysolutions.net/people/matthew-m-schuckmann/69dd0728-6b5d-41e7-834c-416e25a977dc)

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

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