Zoetis Belgium S.A.
Form 483 issued November 22, 2022 · Ottignies-Louvain-la-Neuve, Belgium
- Inspection
- Nov 14 – Nov 22, 2022
- Investigator
- Jose M. Cayuela
- Observations
- 5
- Pages
- 15
- FEI number
- 3010087842
In short: On November 22, 2022, FDA issued a Form 483 with 5 observations to Zoetis Belgium S.A. in Ottignies-Louvain-la-Neuve, Belgium (FEI 3010087842) after an inspection that ran Nov 14 – Nov 22, 2022. The investigator was Jose M. Cayuela. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
The written stability testing…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zoetis Belgium S.A.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Zoetis Belgium S.A.?
Jose M. Cayuela is named on this Form 483, for the inspection of Nov 14 – Nov 22, 2022. Each investigator has a profile showing what they cite most.
When was Zoetis Belgium S.A. inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2022, and the Form 483 is dated November 22, 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.