Omya Inc.
Form 483 issued May 27, 2022 · Superior, Arizona
- Inspection
- May 24 – May 27, 2022
- Investigator
- Nathaniel B. Phillips-Sylvain
- Observations
- 2
- Pages
- 4
- FEI number
- 3003624292
In short: On May 27, 2022, FDA issued a Form 483 with 2 observations to Omya Inc. in Superior, Arizona (FEI 3003624292) after an inspection that ran May 24 – May 27, 2022. The investigator was Nathaniel B. Phillips-Sylvain. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm does not have established appropriate…
- 02
Your firm failed to ensure the quality unit was notified of production equipment alerts and preventative…
This inspection in context
Nathaniel B. Phillips-Sylvain
6 documents · 2020–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Washington.
The firmOmya Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Omya Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Omya Inc.?
Nathaniel B. Phillips-Sylvain is named on this Form 483, for the inspection of May 24 – May 27, 2022. Each investigator has a profile showing what they cite most.
When was Omya Inc. inspected by FDA?
The inspection ran May 24 – May 27, 2022, and the Form 483 is dated May 27, 2022.
How do I get the full Form 483 for Omya 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.