Catalent Massachusetts, LLC
FDA inspection history in Chelsea, Massachusetts, 2021 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Chelsea, Massachusetts.
- 2021The longest 483 on file: 4 observations over 4 pages at Chelsea, Massachusetts.
- 2026One Form 483, at Chelsea, Massachusetts.
Cited most
Across all Catalent Massachusetts observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.67(b)(3)Equipment cleaning and maintenance1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Catalent Massachusetts file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Chelsea, Massachusetts
Two Form 483s · 2021 to 2026 · 5 observations
Latest: Form 483, Apr 7, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-07 | 483 Form 483 | Chelsea, Massachusetts | 1 | $99 |
| 2021-11-30 | 483 Form 483 | Chelsea, Massachusetts | 4 | $99 |
Investigators on these documents
Armen H. Youssoufian (1)Daniel L. Zheng (1)Leanna M. Slarsky (1)Ogechi C. Nna (1)Robert J. Martin (1)
FEI number 3011696115 · most recent document Apr 7, 2026
About Catalent Massachusetts, LLC
How many FDA Form 483s has Catalent Massachusetts, LLC received?
FDA Intel has 2 Form 483s on file for Catalent Massachusetts, LLC; the most recent is dated Apr 7, 2026.
When was Catalent Massachusetts, LLC last inspected by FDA?
The most recent FDA inspection document on file for Catalent Massachusetts, LLC is a Form 483 dated Apr 7, 2026, for the site in Chelsea, Massachusetts.
What did FDA cite at Catalent Massachusetts, LLC?
The regulations cited most in the observations on file for Catalent Massachusetts, LLC are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.67(b)(3) (Equipment cleaning and maintenance), 1 time.