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FDA Inspection
•Huntingdon Life Sciences, Inc.•November 30, 2016

Huntingdon Life Sciences, Inc. – FDA Inspection, Nov 30, 2016

Record Details

This FDA Inspection record concerns Huntingdon Life Sciences, Inc., with an inspection on November 30, 2016, issued by the New Jersey District Office, covering animal drugs & feeds.

Company
Huntingdon Life Sciences, Inc.
Inspection Date
November 30, 2016
Product Type
Animal Drugs & Feeds
Office
New Jersey District Office
People
  • Anastasia I. Onuorah (Company Rep)
  • Denise M. Visco (Company Rep)
View Company Profile

ID · a3fdd278-0312-40b1-ad8c-b4cde9487ac5

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
996465
FDA center
Animal Drugs & Feeds
Project area
Pre-Approval Eval. of Animal Drugs and Food Additives
Outcome
Form 483 issued

FDA Citations

8
  1. 21 CFR 58.113(a)(2)Mixtures: stability
  2. 21 CFR 58.130(a)Conduct: in accordance with protocol
  3. 21 CFR 58.185(a)(10)Final report: names of those involved
  4. 21 CFR 58.185(a)(5)Final report: stability of test and control articles
  5. 21 CFR 58.31(d)Management: testing of test and control articles
  6. 21 CFR 58.33(d)Study director: test system specified in protocol
  7. 21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
  8. 21 CFR 58.81(a)SOPs: authorization and documentation of deviations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Huntingdon Life Sciences, Inc.

2
DateClassificationOfficeProject area
August 1, 2023Not classifiedNew Jersey District Office
September 27, 2017VAINew Jersey District OfficeBioresearch Monitoring
Other documents for Huntingdon Life Sciences, Inc.
  • FDA Inspection 1215898 - 2023-08-01
  • FDA Inspection 1026747 - 2017-09-27

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