# FDA 483 - MassBiologics - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/massbiologics/55d58639-f609-454b-a2a1-0c03a56ff9df

> FDA 483 for MassBiologics on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: MassBiologics, a vaccine manufacturer in Boston, MA, was cited for multiple deficiencies during an FDA inspection. The firm exhibited significant issues with its deviation investigation process, including inadequate documentation, unmonitored corrective and preventative actions, and insufficient root cause analysis. Additionally, the inspection revealed a lack of written procedures for aseptic operations and a failure to certify HEPA filters according to established SOPs.

## Related Documents

- [483 - 2010-07-13](https://www.globalkeysolutions.net/records/483/massbiologics/0a149ddf-e774-426d-9cda-94a22372b436)
- [483 - 2019-11-19](https://www.globalkeysolutions.net/records/483/massbiologics/24eda3f4-f224-42fc-9272-a6f151517450)
- [483 - 2022-09-01](https://www.globalkeysolutions.net/records/483/massbiologics/7697ffb3-e3e5-4b7c-b35f-71dbfed07048)
- [483 - 2025-12-18](https://www.globalkeysolutions.net/records/483/massbiologics/32cddc50-58d8-43da-866b-326888199b33)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [James E. Keller](https://www.globalkeysolutions.net/people/james-e-keller/6d30d4b5-a97a-4825-bcf9-ee57c100eaee)
- [Leslie Wagner](https://www.globalkeysolutions.net/people/leslie-wagner/be24e214-ff08-43d8-9547-51ee27e6b4f2)

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

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