Zoetis Belgium S.A
Form 483 issued March 25, 2022 · RATHDRUM, Ireland
- Inspection
- Mar 21 – Mar 25, 2022
- Investigator
- Junho Pak
- Observations
- 4
- Pages
- 4
- FEI number
- 3015422006
In short: On March 25, 2022, FDA issued a Form 483 with 4 observations to Zoetis Belgium S.A in RATHDRUM, Ireland (FEI 3015422006) after an inspection that ran Mar 21 – Mar 25, 2022. The investigator was Junho Pak. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
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 procedures are not fully documented and investigated…
- 02
The master production and control records are deficient in that they do not include complete manufacturing…
- 03
Equipment calibrations are not conducted on a periodic basis for…
- 04
Management of the training program is not conducted to ensure compliance…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmZoetis Belgium S.A history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zoetis Belgium S.A?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Zoetis Belgium S.A?
Junho Pak is named on this Form 483, for the inspection of Mar 21 – Mar 25, 2022. Each investigator has a profile showing what they cite most.
When was Zoetis Belgium S.A inspected by FDA?
The inspection ran Mar 21 – Mar 25, 2022, and the Form 483 is dated March 25, 2022.
How do I get the full Form 483 for Zoetis Belgium S.A?
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.