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FDA Inspection
•OSRX Inc.•April 25, 2019

OSRX Inc. – FDA Inspection, Apr 25, 2019

Record Details

This FDA Inspection record concerns OSRX Inc., with an inspection on April 25, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
OSRX Inc.
Inspection Date
April 25, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Andrew K. Haack (FDA Associated Person)
  • Christopher R. Czajka (FDA Associated Person)
View Company Profile

ID · dd0491e1-78cc-4e97-8abb-8c123ea117df

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1087576
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

1
  1. FDCA 501(a)(2)(A)Inadequate filter, final product sterilization

Full citation text and observation details available on the Dashboard.

Other FDA inspections of OSRX Inc.

3
DateClassificationOfficeProject area
November 14, 2025Not classifiedSeattle District OfficeDrug Quality Assurance
October 25, 2024OAISeattle District OfficeDrug Quality Assurance
September 23, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for OSRX Inc.
  • FDA Inspection 1283268 - 2025-11-14
  • FDA Inspection 1246254 - 2024-10-25
  • FDA Inspection 1154392 - 2021-09-23

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