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FDA Inspection
•American Regent Inc.•June 18, 2026

American Regent Inc. – FDA Inspection, Jun 18, 2026

Record Details

This FDA Inspection record concerns American Regent Inc., with an inspection on June 18, 2026, issued by the Cincinnati District Office, covering human drugs.

Company
American Regent Inc.
Inspection Date
June 18, 2026
Product Type
Human Drugs
Office
Cincinnati District Office
Person
  • Geoffrey K. Kilili (Company Rep)
View Company Profile

ID · 30a82799-2842-4616-b853-dc2b8e681709

Inspection Facts

Inspection number
1323508
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of American Regent Inc.

8
DateClassificationOfficeProject area
July 20, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 8, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 2, 2017Not classifiedCincinnati District Office
August 18, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
December 7, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
Other documents for American Regent Inc.
  • FDA Inspection 1210501 - 2023-07-20
  • FDA Inspection 1083384 - 2019-03-08
  • FDA Inspection 1032342 - 2017-11-02
  • FDA Inspection 1024378 - 2017-08-18
  • FDA Inspection 997579 - 2016-12-07

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