Everzinc Corporation
Form 483 issued January 12, 2024 · Millington, Tennessee
- Inspection
- Jan 8 – Jan 12, 2024
- Investigator
- Dario L. Wells
- Observations
- 2
- Pages
- 3
- FEI number
- 3010166197
In short: On January 12, 2024, FDA issued a Form 483 with 2 observations to Everzinc Corporation in Millington, Tennessee (FEI 3010166197) after an inspection that ran Jan 8 – Jan 12, 2024. The investigator was Dario L. Wells. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to exercise sufficient controls over computerized systems to prevent the…
- 02
Failure to use primary reference standard in…
This inspection in context
Dario L. Wells
1 document · 2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Tennessee.
The firmEverzinc Corporation 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 Everzinc Corporation?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. 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 Everzinc Corporation?
Dario L. Wells is named on this Form 483, for the inspection of Jan 8 – Jan 12, 2024. Each investigator has a profile showing what they cite most.
When was Everzinc Corporation inspected by FDA?
The inspection ran Jan 8 – Jan 12, 2024, and the Form 483 is dated January 12, 2024.
How do I get the full Form 483 for Everzinc Corporation?
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.