Norbitec GmbH
FDA inspection history in Uetersen, Germany, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Uetersen, Germany.
Cited most
Across all Norbitec observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.58Maintenance1
The complete Norbitec file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Uetersen, Germany
One Form 483 · 2023 · 4 observations
Latest: Form 483, Apr 6, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-06 | 483 Form 483 | Uetersen, Germany | 4 | $99 |
Investigators on these documents
FEI number 3010763764 · most recent document Apr 6, 2023
About Norbitec GmbH
How many FDA Form 483s has Norbitec GmbH received?
FDA Intel has 1 Form 483 on file for Norbitec GmbH; the most recent is dated Apr 6, 2023.
When was Norbitec GmbH last inspected by FDA?
The most recent FDA inspection document on file for Norbitec GmbH is a Form 483 dated Apr 6, 2023, for the site in Uetersen, Germany.
What did FDA cite at Norbitec GmbH?
The regulations cited most in the observations on file for Norbitec GmbH are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.