Aurorium LLC
FDA inspection history in Zeeland, Michigan, 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 Zeeland, Michigan.
Cited most
Across all Aurorium observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.105Equipment identification1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Aurorium file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Zeeland, Michigan
One Form 483 · 2019
Latest: Form 483, Apr 9, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-09 | 483 Form 483 | Zeeland, Michigan | — | $99 |
Investigators on these documents
FEI number 1824624 · most recent document Apr 9, 2019
About Aurorium LLC
How many FDA Form 483s has Aurorium LLC received?
FDA Intel has 1 Form 483 on file for Aurorium LLC; the most recent is dated Apr 9, 2019.
When was Aurorium LLC last inspected by FDA?
The most recent FDA inspection document on file for Aurorium LLC is a Form 483 dated Apr 9, 2019, for the site in Zeeland, Michigan.
What did FDA cite at Aurorium LLC?
The regulations cited most in the observations on file for Aurorium LLC are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.105 (Equipment identification), 1 time; 21 CFR 211.192 (Production record review), 1 time.