AVA, Inc.
Form 483 issued March 30, 2016 · Willowbrook, Illinois
- Inspection
- Mar 15 – Mar 30, 2016
- Investigator
- Christina A. Miller
- Observations
- 4
- Pages
- 3
- FEI number
- 3008736380
In short: On March 30, 2016, FDA issued a Form 483 with 4 observations to AVA, Inc. in Willowbrook, Illinois (FEI 3008736380) after an inspection that ran Mar 15 – Mar 30, 2016. The investigator was Christina A. Miller. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control records…
- 02
Routine calibration, inspection, and checking of mechanical and electronic equipment is not performed according to a…
- 03
Deviations from written production and process control records are…
- 04
The results of the examination of the packaged and labeled products were not documented in the…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AVA, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected AVA, Inc.?
Christina A. Miller is named on this Form 483, for the inspection of Mar 15 – Mar 30, 2016. Each investigator has a profile showing what they cite most.
When was AVA, Inc. inspected by FDA?
The inspection ran Mar 15 – Mar 30, 2016, and the Form 483 is dated March 30, 2016.
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.