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

Source: https://www.keypedia.com/records/483/massbiologics-south-coast/58db7b0c-fb4a-4d2e-9505-b4137291b74f

> 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: New England District Office
- Summary: An FDA inspection of MassBiologics South Coast in Fall River, MA, revealed multiple significant deficiencies in their manufacturing and quality control processes. The firm was cited for inadequate environmental monitoring, untimely closure of deviations, and poor facility maintenance. Additionally, observations included insufficient detail in standard operating procedures, failure to follow established protocols, and a lack of proper control over their document management system.

## Related Documents

- [483 - 2024-08-12](https://www.keypedia.com/records/483/massbiologics-south-coast/25337011-c513-43f2-a12a-de640e4109e9)

## Related Officers

- [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)
- [Donald B. Ertel](https://www.keypedia.com/people/donald-b-ertel/f5589062-4790-47df-8763-09aba06af4d6)
- [Susan S. Butler](https://www.keypedia.com/people/susan-s-butler/45011bf3-2074-4150-aafe-1eac320c0864)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144