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FDA Inspection
•SGS North America Inc.•June 9, 2026

SGS North America Inc. – FDA Inspection, Jun 9, 2026

Record Details

This FDA Inspection record concerns SGS North America Inc., with an inspection on June 9, 2026, issued by the New Jersey District Office, covering human drugs.

Company
SGS North America Inc.
Inspection Date
June 9, 2026
Product Type
Human Drugs
Office
New Jersey District Office
People
  • Janet A. Rajan (FDA Associated Person)
  • Stephenie M. Ortiz (Investigator)
  • Suchan Kim (Investigator)
View Company Profile

ID · 19f7bf6c-95d5-4ab7-b207-dd53edeedef6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1321138
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SGS North America Inc.

7
DateClassificationOfficeProject area
August 1, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 30, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 7, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 21, 2014VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
November 21, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for SGS North America Inc.
  • FDA Inspection 1211177 - 2023-08-01
  • FDA Inspection 1027721 - 2017-08-30
  • FDA Inspection 973286 - 2016-06-07
  • FDA Inspection 862181 - 2014-01-21
  • FDA Inspection 753526 - 2011-11-21

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Contact
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