Merck Sharp & Dohme LLC
FDA inspection history in West Point, Pennsylvania, 2012 to 2024
- 5
- Form 483s
- 1
- Response
- 1
- EIR
- 1
- Close-out
Every document, by year
- Form 483
- Response
- EIR
- Close-out
2012: one close-out letter; 2015: one Form 483; 2017: one inspection report; 2019: two Form 483s and one 483 response; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One close-out letter.
- 2015–21Four Form 483s, one inspection report and one 483 response, at West Point, Pennsylvania.
- 2015The longest 483 on file: 16 observations over 16 pages at West Point, Pennsylvania.
- 2024One Form 483, at West Point, Pennsylvania.
Cited most
Across all Merck Sharp & Dohme observations on file
- 21 CFR 211.192Production record review7
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.113Control of microbiological contamination2
The complete Merck Sharp & Dohme file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
West Point, Pennsylvania
Five Form 483s, one 483 response and one inspection report · 2015 to 2024 · 39 observations
Latest: Form 483, Aug 23, 2024 →
Also: one document not tied to a site.
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-23 | 483 Form 483 | West Point, Pennsylvania | 3 | $99 |
| 2021-07-27 | 483 Form 483 | West Point, Pennsylvania | 4 | $99 |
| 2019-10-07 | Response 483 response | West Point, Pennsylvania | — | $199 |
| 2019-09-20 | 483 Form 483 | West Point, Pennsylvania | 15 | $99 |
| 2019-04-30 | 483 Form 483 | West Point, Pennsylvania | 1 | $99 |
| 2017-04-28 | EIR EIR | West Point, Pennsylvania | — | $550 |
| 2015-04-17 | 483 Form 483 | West Point, Pennsylvania | 16 | $99 |
| 2012-02-17 | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
Linda Thai (2)Biologics X. Beene (1)Biologics X. Suse (1)Brentley Collins (1)Chris J. Adams (1)Craig D. Zagata (1)Cynthia Jim (1)Eileen A. Liu (1)Gene D. Arcy (1)Haruhiko Murata (1)Kelly N. Kerr (1)Marian Major (1)
FEI number 2510592 · most recent document Aug 23, 2024
About Merck Sharp & Dohme LLC
How many FDA Form 483s has Merck Sharp & Dohme LLC received?
FDA Intel has 5 Form 483s on file for Merck Sharp & Dohme LLC; the most recent is dated Aug 23, 2024.
When was Merck Sharp & Dohme LLC last inspected by FDA?
The most recent FDA inspection document on file for Merck Sharp & Dohme LLC is a Form 483 dated Aug 23, 2024, for the site in West Point, Pennsylvania.
What did FDA cite at Merck Sharp & Dohme LLC?
The regulations cited most in the observations on file for Merck Sharp & Dohme LLC are 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.42 (Design and construction features), 3 times.