# FDA 483 - MassBiologics South Coast - August 12, 2024

Source: https://www.keypedia.com/records/483/massbiologics-south-coast/25337011-c513-43f2-a12a-de640e4109e9

> FDA 483 for MassBiologics South Coast on August 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics South Coast
- Inspection Date: 2024-08-12
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of MassBiologics South Coast in Fall River, MA, revealed six significant observations. The firm exhibited deficiencies in environmental monitoring practices and the timely closure of deviations and investigations. Additionally, the facility was not maintained in a good state of repair, and standard operating procedures lacked sufficient detail or were not followed, alongside issues with document management.

## Related Officers

- [Susan S. Butler](https://www.keypedia.com/people/susan-s-butler/45011bf3-2074-4150-aafe-1eac320c0864)
- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [issuing_officer](https://www.keypedia.com/people/kinjal-s-patel/95b05da2-7138-4443-8667-1338137bd785)
- [Bo Liang](https://www.keypedia.com/people/bo-liang/9902f822-7544-4e11-8cdc-49a99627db13)

Company: https://www.keypedia.com/companies/massbiologics-south-coast/bfed264e-18bc-497e-b0a8-29449b985350

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd