Zoetis LLC
Form 483 issued May 23, 2022 · Lincoln, Nebraska
- Inspection
- May 23, 2022
- Observations
- 2
- Pages
- 4
- FEI number
- 1910179
In short: On May 23, 2022, FDA issued a Form 483 with 2 observations to Zoetis LLC in Lincoln, Nebraska (FEI 1910179) after an inspection that ran May 23, 2022. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Questions about this 483
What did FDA find at Zoetis LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Zoetis LLC inspected by FDA?
The inspection ran May 23, 2022, and the Form 483 is dated May 23, 2022.
How do I get the full Form 483 for Zoetis LLC?
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.