# FDA 483 - MassBiologics - December 18, 2025

Source: https://www.globalkeysolutions.net/records/483/massbiologics/32cddc50-58d8-43da-866b-326888199b33

> FDA 483 for MassBiologics on December 18, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MassBiologics
- Inspection Date: 2025-12-18
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of MassBiologics, a Gene Therapy Testing Lab in Boston, revealed a significant deficiency regarding written procedures. The firm failed to establish and follow written procedures for annual evaluations, including reviews of complaints, recalls, and investigations for each drug product. Specifically, quality indicator reports for Kebilidi manufacturing lacked proper documentation and visual representation of drug product batch release data trends.

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## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

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

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