Merck Teknika LLC
FDA inspection history in Durham, North Carolina, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Durham, North Carolina.
Cited most
Across all Merck Teknika observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.142Warehousing procedures1
The complete Merck Teknika file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Durham, North Carolina
One Form 483 · 2020 · 10 observations
Latest: Form 483, Jan 24, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-01-24 | 483 Form 483 | Durham, North Carolina | 10 | $99 |
Investigators on these documents
Marla A. Cassidy (1)Mihaly S. Ligmond (1)Steven E. Bowen (1)
FEI number 1039284 · most recent document Jan 24, 2020
About Merck Teknika LLC
How many FDA Form 483s has Merck Teknika LLC received?
FDA Intel has 1 Form 483 on file for Merck Teknika LLC; the most recent is dated Jan 24, 2020.
When was Merck Teknika LLC last inspected by FDA?
The most recent FDA inspection document on file for Merck Teknika LLC is a Form 483 dated Jan 24, 2020, for the site in Durham, North Carolina.
What did FDA cite at Merck Teknika LLC?
The regulations cited most in the observations on file for Merck Teknika LLC are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.