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FDA Inspection
•Organon LLC•September 15, 2026

Organon LLC – FDA Inspection, Sep 15, 2026

Record Details

This FDA Inspection record concerns Organon LLC, with an inspection on September 15, 2026, issued by the New Jersey District Office, covering human drugs.

Company
Organon LLC
Inspection Date
September 15, 2026
Product Type
Human Drugs
Office
New Jersey District Office
Person
  • Jay B. Shah (FDA Associated Person)
View Company Profile

ID · 244ed64d-62d5-4b89-b82e-0ec596766888

Inspection Facts

Inspection number
1289600
FDA center
Human Drugs
Project area
Postmarket Surv. and Epidemiology
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR

Full citation text and observation details available on the Dashboard.

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