Amsino Healthcare (USA) Inc.
FDA inspection history in Vernon Hills, Illinois, 2021 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Three Form 483s, at Vernon Hills, Illinois.
- 2022The longest 483 on file: 16 observations over 21 pages at Vernon Hills, Illinois.
Cited most
Across all Amsino Healthcare (USA) observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance4
- 21 CFR 820.30(b)Design controls4
- 21 CFR 211.192Production record review3
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 211.113(b)Control of microbiological contamination2
The complete Amsino Healthcare (USA) file.
All 3 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
Vernon Hills, Illinois
Three Form 483s · 2021 to 2023 · 26 observations
Latest: Form 483, Nov 13, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-13 | 483 Form 483 | Vernon Hills, Illinois | — | $99 |
| 2022-12-19 | 483 Form 483 | Vernon Hills, Illinois | 16 | $99 |
| 2021-09-20 | 483 Form 483 | Vernon Hills, Illinois | 10 | $99 |
Investigators on these documents
Joseph A. Piechocki (1)Michele L. Glendenning (1)Shafig Ahadi (1)Shafiq S. Ahadi (1)Simone E. Pitts (1)
FEI number 1417519 · most recent document Nov 13, 2023
About Amsino Healthcare (USA) Inc.
How many FDA Form 483s has Amsino Healthcare (USA) Inc. received?
FDA Intel has 3 Form 483s on file for Amsino Healthcare (USA) Inc.; the most recent is dated Nov 13, 2023.
When was Amsino Healthcare (USA) Inc. last inspected by FDA?
The most recent FDA inspection document on file for Amsino Healthcare (USA) Inc. is a Form 483 dated Nov 13, 2023, for the site in Vernon Hills, Illinois.
What did FDA cite at Amsino Healthcare (USA) Inc.?
The regulations cited most in the observations on file for Amsino Healthcare (USA) Inc. are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 4 times; 21 CFR 820.30(b) (Design controls), 4 times; 21 CFR 211.192 (Production record review), 3 times.