Nordmark Pharma GmbH
FDA inspection history in Uetersen, Germany, 2017 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Uetersen, Germany.
- 2017The longest 483 on file: 3 observations over 3 pages at Uetersen, Germany.
Cited most
Across all Nordmark Pharma observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Nordmark Pharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Uetersen, Germany
Two Form 483s · 2017 to 2019 · 5 observations
Latest: Form 483, Aug 16, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-16 | 483 Form 483 | Uetersen, Germany | 2 | $99 |
| 2017-02-17 | 483 Form 483 | Uetersen, Germany | 3 | $99 |
Investigators on these documents
FEI number 3003293533 · most recent document Aug 16, 2019
About Nordmark Pharma GmbH
How many FDA Form 483s has Nordmark Pharma GmbH received?
FDA Intel has 2 Form 483s on file for Nordmark Pharma GmbH; the most recent is dated Aug 16, 2019.
When was Nordmark Pharma GmbH last inspected by FDA?
The most recent FDA inspection document on file for Nordmark Pharma GmbH is a Form 483 dated Aug 16, 2019, for the site in Uetersen, Germany.
What did FDA cite at Nordmark Pharma GmbH?
The regulations cited most in the observations on file for Nordmark Pharma GmbH are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.180 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.