# FDA 483 - University of Massachusetts Incorporated - November 01, 2022

Source: https://www.globalkeysolutions.net/records/483/university-of-massachusetts-incorporated/9a6cdaac-be85-4d73-81e2-1c3737e8c16d

> FDA 483 for University of Massachusetts Incorporated on November 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Massachusetts Incorporated
- Inspection Date: 2022-11-01
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of University of Massachusetts Incorporated in Worcester, MA, a QC Laboratory, revealed significant deficiencies in quality control unit responsibilities, laboratory record-keeping, and equipment maintenance. The firm failed to qualify an animal supplier for cGMP testing and lacked proper tracking for in-process samples. Additionally, laboratory records were not reviewed by a second person, and preventative maintenance procedures for critical equipment were not followed as established.

## Related Officers

- [Laurel A. Beer](https://www.globalkeysolutions.net/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.globalkeysolutions.net/companies/university-of-massachusetts-incorporated/a9ec28fe-9d2a-4259-8967-78eda631a711

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7