# FDA 483 - Lafayette Work Center, Inc. - August 26, 2019

Source: https://www.globalkeysolutions.net/records/483/lafayette-work-center-inc/657326b7-d319-47b3-b8f2-b02f08f478e1

> FDA 483 for Lafayette Work Center, Inc. on August 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lafayette Work Center, Inc.
- Inspection Date: 2019-08-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Lafayette Industries North, Inc., a drug repackager and relabeler in Berkley, MO, was cited for three observations during an FDA inspection. Deficiencies included inadequate procedures and documentation for handling drug product complaints, lack of documented training for core staff and management, and failure to maintain written records for major equipment cleaning, maintenance, and use. These issues indicate significant non-compliance with current good manufacturing practice regulations.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.globalkeysolutions.net/companies/lafayette-work-center-inc/127eb15d-c519-4a5c-85bd-b35ff6e16234

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