Merck Sharp & Dohme LLC
FDA inspection history in Elkton, Virginia, 2012 to 2025
- 5
- Form 483s
Every document, by year
- Form 483
2012: one Form 483; 2018: one Form 483; 2019: one Form 483; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One Form 483, at Elkton, Virginia.
- 2018–20Three Form 483s, at Elkton, Virginia.
- 2018The longest 483 on file: 6 observations over 7 pages at Elkton, Virginia.
- 2025One Form 483, at Elkton, Virginia.
Cited most
Across all Merck Sharp & Dohme observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Merck Sharp & Dohme file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Elkton, Virginia
Five Form 483s · 2012 to 2025 · 20 observations
Latest: Form 483, Jan 22, 2025 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-22 | 483 Form 483 | Elkton, Virginia | 6 | $99 |
| 2020-03-04 | 483 Form 483 | Elkton, Virginia | 4 | $99 |
| 2019-06-28 | 483 Form 483 | Elkton, Virginia | 2 | $99 |
| 2018-10-26 | 483 Form 483 | Elkton, Virginia | 6 | $99 |
| 2012-08-24 | 483 Form 483 | Elkton, Virginia | 2 | $99 |
Investigators on these documents
Brandy N. Lepage (1)Brooke K. Higgins (1)Burnell M. Henry (1)David A. Oluwo (1)Justin A. Boyd (1)Nebil A. Oumer (1)Susan M. Jackson (1)
FEI number 1112271 · most recent document Jan 22, 2025
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 Jan 22, 2025.
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 Jan 22, 2025, for the site in Elkton, Virginia.
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), 6 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.