AVA, Inc.
FDA inspection history in Willowbrook, Illinois, 2016 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2021: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Willowbrook, Illinois.
- 2016The longest 483 on file: 4 observations over 3 pages at Willowbrook, Illinois.
- 2021One Form 483, at Willowbrook, Illinois.
- 2026One warning letter, at Willowbrook, Illinois.
Cited most
Across all AVA observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.125(a)Labeling issuance2
- 21 CFR 211.134Drug product inspection1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete AVA 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
Willowbrook, Illinois
Two Form 483s and one warning letter · 2016 to 2026 · 6 observations
Latest: Warning letter, Apr 14, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-14 | Warning letter Warning letter | Willowbrook, Illinois | — | $99 |
| 2021-09-29 | 483 Form 483 | Willowbrook, Illinois | 2 | $99 |
| 2016-03-30 | 483 Form 483 | Willowbrook, Illinois | 4 | $99 |
Investigators on these documents
FEI number 3008736380 · most recent document Apr 14, 2026
About AVA, Inc.
How many FDA Form 483s has AVA, Inc. received?
FDA Intel has 2 Form 483s on file for AVA, Inc.; the most recent is dated Sep 29, 2021.
When was AVA, Inc. last inspected by FDA?
The most recent FDA inspection document on file for AVA, Inc. is a Form 483 dated Sep 29, 2021, for the site in Willowbrook, Illinois.
What did FDA cite at AVA, Inc.?
The regulations cited most in the observations on file for AVA, Inc. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.125(a) (Labeling issuance), 2 times; 21 CFR 211.134 (Drug product inspection), 1 time.
Has AVA, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for AVA, Inc.; the most recent is dated Apr 14, 2026.