Catalent Maryland, Inc.
FDA inspection history in Harmans, Maryland, 2020 to 2025
- 4
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2020: one Form 483; 2021: one Form 483; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–25Four Form 483s, at Harmans, Maryland.
- 2025The longest 483 on file: 6 observations over 3 pages at Harmans, Maryland.
Cited most
Across all Catalent Maryland observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.42Design and construction features3
The complete Catalent Maryland file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Harmans, Maryland
Four Form 483s and one inspection report · 2020 to 2025 · 13 observations
Latest: Form 483, Apr 28, 2025 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-28 | 483 Form 483 | Harmans, Maryland | 6 | $99 |
| 2023-03-10 | 483 Form 483 | Harmans, Maryland | 2 | $99 |
| 2021-11-17 | 483 Form 483 | Harmans, Maryland | — | $99 |
| 2020-06-19 | 483 Form 483 | Harmans, Maryland | 5 | $99 |
| Undated | EIR EIR | Harmans, Maryland | — | $550 |
Investigators on these documents
Alifiya H. Ghadiali (1)Bace Yan Wt Viheed (1)Ou Olivia Ma (1)Sarah Underwood (1)Sukyoung Sohn (1)
FEI number 3015434301 · most recent document Apr 28, 2025
About Catalent Maryland, Inc.
How many FDA Form 483s has Catalent Maryland, Inc. received?
FDA Intel has 4 Form 483s on file for Catalent Maryland, Inc.; the most recent is dated Apr 28, 2025.
When was Catalent Maryland, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Catalent Maryland, Inc. is a Form 483 dated Apr 28, 2025, for the site in Harmans, Maryland.
What did FDA cite at Catalent Maryland, Inc.?
The regulations cited most in the observations on file for Catalent Maryland, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.