# FDA 483 - MassBiologics - November 19, 2019

Source: https://www.globalkeysolutions.net/records/483/massbiologics/24eda3f4-f224-42fc-9272-a6f151517450

> FDA 483 for MassBiologics on November 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics
- Inspection Date: 2019-11-19
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: MassBiologics, a vaccine manufacturer in Boston, MA, received an FDA Form 483 citing significant deficiencies across its operations. The observations highlight inadequate validation of aseptic and sterilization processes, insufficient control procedures for manufacturing, and a failure to thoroughly investigate discrepancies and implement timely corrective actions. Additional concerns include poor data integrity, lack of proper supplier qualification, and non-compliance with change control and complaint handling procedures.

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## Related Officers

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- [Leslie Wright, CSO](https://www.globalkeysolutions.net/people/leslie-wright-cso/d26df8dc-47f5-4f18-a0d4-842d39f3291b)
- [Lindsey Lyman, Biologist](https://www.globalkeysolutions.net/people/lindsey-lyman-biologist/16c79230-f05c-4686-9151-f3adf2b4a19a)

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