Apex International Mfg., LLC
FDA inspection history in Chaska, Minnesota, 2015 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Chaska, Minnesota.
- 2023One Form 483, at Chaska, Minnesota.
- 2023The longest 483 on file: 3 observations over 4 pages at Chaska, Minnesota.
Cited most
Across all Apex International Mfg. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Apex International Mfg. 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
Chaska, Minnesota
Two Form 483s · 2015 to 2023 · 4 observations
Latest: Form 483, Aug 11, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-11 | 483 Form 483 | Chaska, Minnesota | 3 | $99 |
| 2015-01-27 | 483 Form 483 | Chaska, Minnesota | 1 | $99 |
Investigators on these documents
FEI number 2130334 · most recent document Aug 11, 2023
About Apex International Mfg., LLC
How many FDA Form 483s has Apex International Mfg., LLC received?
FDA Intel has 2 Form 483s on file for Apex International Mfg., LLC; the most recent is dated Aug 11, 2023.
When was Apex International Mfg., LLC last inspected by FDA?
The most recent FDA inspection document on file for Apex International Mfg., LLC is a Form 483 dated Aug 11, 2023, for the site in Chaska, Minnesota.
What did FDA cite at Apex International Mfg., LLC?
The regulations cited most in the observations on file for Apex International Mfg., LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.