Atlas

Form 483

Zoetis Belgium S.A. Form 483, 2016-08-25

FDA issued a Form 483 to Zoetis Belgium S.A. on 2016-08-25 with 3 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds3 observations

Zoetis Belgium S.A. · Louvain-la-Neuve, Belgium · Issued August 25, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

25 Aug 2016
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Satheesh Thomas, Xiaoping Guan

25 Aug 2016
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Satheesh Thomas, Xiaoping Guan

25 Aug 2016
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Satheesh Thomas, Xiaoping Guan

Inspected site

ZBZoetis Belgium S.A.Louvain-la-Neuve, Belgium

Inspection team

STSatheesh Thomas
XGXiaoping Guan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere