FEI 3008587095
FDA inspection history in Gottingen, Germany, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Gottingen, Germany.
Cited most
Across all site observations on file
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
The complete site file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gottingen, Germany
One Form 483 · 2019 · 7 observations
Latest: Form 483, Jul 12, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-07-12 | 483 Form 483 | Gottingen, Germany | 7 | $99 |
Investigators on these documents
FEI number 3008587095 · most recent document Jul 12, 2019
About FEI 3008587095
How many FDA Form 483s has FEI 3008587095 received?
FDA Intel has 1 Form 483 on file for FEI 3008587095; the most recent is dated Jul 12, 2019.
When was FEI 3008587095 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3008587095 is a Form 483 dated Jul 12, 2019, for the site in Gottingen, Germany.
What did FDA cite at FEI 3008587095?
The regulations cited most in the observations on file for FEI 3008587095 are 21 CFR 211.188 (Batch production and control records), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time.