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1246254

OSRX Inc. — FEI 3014549846

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 25, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Missoula, MT (United States)

Facility

Other inspections at this facility

  • 1154392 (VAI Thu Sep 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087576 (VAI Thu Apr 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202721 CFR 211.192Investigations of discrepancies, failures
22789FDCA 503B(a)(10)(B)Drug product container, fails to include