AVA, Inc.
Form 483 issued September 29, 2021 · Willowbrook, Illinois
- Inspection
- Sep 23 – Sep 29, 2021
- Investigator
- Alan M. Roberts
- Observations
- 2
- Pages
- 3
- FEI number
- 3008736380
In short: On September 29, 2021, FDA issued a Form 483 with 2 observations to AVA, Inc. in Willowbrook, Illinois (FEI 3008736380) after an inspection that ran Sep 23 – Sep 29, 2021. The investigator was Alan M. Roberts. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.125 (labeling issuance).
At a glance
2 of 2 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.125(f) (1×) · 211.125(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing in sufficient detail the controls employed for the issuance of…
- 02
Strict control is not exercised over labeling issued for use in…
This inspection in context
Alan M. Roberts
4 documents · 2019–2021
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmAVA, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.125(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AVA, Inc.?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.125 (labeling issuance). The opening words of each observation are shown on this page.
Who inspected AVA, Inc.?
Alan M. Roberts is named on this Form 483, for the inspection of Sep 23 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was AVA, Inc. inspected by FDA?
The inspection ran Sep 23 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
How do I get the full Form 483 for AVA, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.