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1007560

SterRx, LLC — FEI 3010840309

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Plattsburgh, NY (United States)

Facility

Other inspections at this facility

  • 1209342 (OAI Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156750 (OAI Thu Nov 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
18008FDCA 503B(a)(10)Drug product label, outsourcer facility
435721 CFR 211.166(a)Results not used for expiration dates, storage cond.