Form FDA 483 Merck Teknika LLC Durham November 2024
FDA inspection history in Du rham, North Carolina, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Du rham, North Carolina.
Cited most
Across all Form FDA 483 Merck Teknika LLC Durham November 2024 observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Form FDA 483 Merck Teknika LLC Durham November 2024 file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Du rham, North Carolina
One Form 483 · 2024 · 6 observations
Latest: Form 483, Nov 27, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-27 | 483 Form 483 | Du rham, North Carolina | 6 | $99 |
Investigators on these documents
About Form FDA 483 Merck Teknika LLC Durham November 2024
How many FDA Form 483s has Form FDA 483 Merck Teknika LLC Durham November 2024 received?
FDA Intel has 1 Form 483 on file for Form FDA 483 Merck Teknika LLC Durham November 2024; the most recent is dated Nov 27, 2024.
When was Form FDA 483 Merck Teknika LLC Durham November 2024 last inspected by FDA?
The most recent FDA inspection document on file for Form FDA 483 Merck Teknika LLC Durham November 2024 is a Form 483 dated Nov 27, 2024, for the site in Du rham, North Carolina.
What did FDA cite at Form FDA 483 Merck Teknika LLC Durham November 2024?
The regulations cited most in the observations on file for Form FDA 483 Merck Teknika LLC Durham November 2024 are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.