Merck Sharp & Dohme LLC
FDA inspection history in Durham, North Carolina, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Durham, North Carolina.
Cited most
Across all Merck Sharp & Dohme observations on file
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 211.58Maintenance1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
- 21 CFR 211.80(b)General requirements1
The complete Merck Sharp & Dohme file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Durham, North Carolina
One Form 483 · 2021 · 5 observations
Latest: Form 483, Apr 16, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-04-16 | 483 Form 483 | Durham, North Carolina | 5 | $99 |
Investigators on these documents
FEI number 3006525584 · most recent document Apr 16, 2021
About Merck Sharp & Dohme LLC
How many FDA Form 483s has Merck Sharp & Dohme LLC received?
FDA Intel has 1 Form 483 on file for Merck Sharp & Dohme LLC; the most recent is dated Apr 16, 2021.
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 Apr 16, 2021, for the site in Durham, North Carolina.
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 211.188 (Batch production and control records), 1 time; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time; 21 CFR 211.58 (Maintenance), 1 time.