Zoetis LLC
Form 483 issued January 14, 2015 · Lincoln, Nebraska
- Inspection
- Jan 5 – Jan 14, 2015
- Observations
- 3
- Pages
- 5
- FEI number
- 1910179
In short: On January 14, 2015, FDA issued a Form 483 with 3 observations to Zoetis LLC in Lincoln, Nebraska (FEI 1910179) after an inspection that ran Jan 5 – Jan 14, 2015. Most observations concern quality system.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Questions about this 483
What did FDA find at Zoetis LLC?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
When was Zoetis LLC inspected by FDA?
The inspection ran Jan 5 – Jan 14, 2015, and the Form 483 is dated January 14, 2015.
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.