# FDA 483 - MassBiologics - September 01, 2022

Source: https://www.globalkeysolutions.net/records/483/massbiologics/7697ffb3-e3e5-4b7c-b35f-71dbfed07048

> FDA 483 for MassBiologics on September 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics
- Inspection Date: 2022-09-01
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of MassBiologics in Boston, MA, a vaccine manufacturer, revealed significant deficiencies across three observations. These issues include inadequate aseptic filling procedures, disorganized and potentially compromised storage of in-process and finished product samples, and a general lack of cleanliness and sanitation in manufacturing and storage facilities. The findings indicate a need for improved contamination control and adherence to good manufacturing practices.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/massbiologics/fa584e7c-22de-470c-836a-dd3028fae600

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