Athea Laboratories Inc.
FDA inspection history in Milwaukee, Wisconsin, 2017 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Milwaukee, Wisconsin.
- 2023One Form 483, at Milwaukee, Wisconsin.
- 2023The longest 483 on file: 2 observations over 4 pages at Milwaukee, Wisconsin.
Cited most
Across all Athea Laboratories observations on file
- 21 CFR 211.42(c)(5)Design and construction features2
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Athea Laboratories 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
Milwaukee, Wisconsin
Two Form 483s · 2017 to 2023 · 4 observations
Latest: Form 483, Dec 20, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-20 | 483 Form 483 | Milwaukee, Wisconsin | 2 | $99 |
| 2017-01-25 | 483 Form 483 | Milwaukee, Wisconsin | 2 | $99 |
Investigators on these documents
FEI number 3010165256 · most recent document Dec 20, 2023
About Athea Laboratories Inc.
How many FDA Form 483s has Athea Laboratories Inc. received?
FDA Intel has 2 Form 483s on file for Athea Laboratories Inc.; the most recent is dated Dec 20, 2023.
When was Athea Laboratories Inc. last inspected by FDA?
The most recent FDA inspection document on file for Athea Laboratories Inc. is a Form 483 dated Dec 20, 2023, for the site in Milwaukee, Wisconsin.
What did FDA cite at Athea Laboratories Inc.?
The regulations cited most in the observations on file for Athea Laboratories Inc. are 21 CFR 211.42(c)(5) (Design and construction features), 2 times; 21 CFR 211.165(f) (Testing and release for distribution), 1 time; 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.