# Catalent Massachusetts, LLC – FDA 483, Nov 30, 2021

Source: https://www.keypedia.com/records/483/catalent-massachusetts-llc/34e634e0-938c-4d07-9487-76f1d7f953a4

> FDA 483 for Catalent Massachusetts, LLC on November 30, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Massachusetts, LLC
- Inspection Date: 2021-11-30
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Catalent Massachusetts, LLC, a drug product manufacturer in Chelsea, MA, revealed significant deficiencies across four observations. The firm was cited for inadequate equipment requalification, insufficient procedures to prevent objectionable microorganisms, and failure to validate supplier analyses for components. Additionally, cleaning and maintenance procedures for GMP manufacturing areas were found to be deficient.

## Related Documents

- [483 - 2026-04-07](https://www.keypedia.com/records/483/catalent-massachusetts-llc/165b83f9-2f4e-411a-b98f-cfe1517acbbe) — date: April 7, 2026
- [483_RESPONSE - 2021-11-30](https://www.keypedia.com/records/483_response/catalent-massachusetts-llc/8d25ff3a-58a8-4a82-87e1-316cbb169542) — date: November 30, 2021
- [EIR - 2021-11-30](https://www.keypedia.com/records/eir/catalent-massachusetts-llc/83021e31-21fd-4de5-9070-fd2b59140cee) — date: November 30, 2021

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)
- [Investigator](https://www.keypedia.com/people/leanna-m-slarsky/9b79fd53-ec91-42bf-aba4-ab106fee9cbc)
- [Daniel B. Sweitzer](https://www.keypedia.com/people/daniel-b-sweitzer/0a03cb75-dca0-4bcc-a94f-b1db1893c240)
- [Robert Scott](https://www.keypedia.com/people/robert-scott/97ee60c1-66a5-475f-9b54-7808c9519d70)

Company: https://www.keypedia.com/companies/catalent-massachusetts-llc/26c89be4-8caa-4cb8-a699-31729cda5497

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94