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1150563

Hybrid Pharma LLC — FEI 3011319445

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 3, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Deerfield Beach, FL (United States)

Facility

Other inspections at this facility

  • 1093987 (OAI Thu Jun 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983055 (OAI Thu Jul 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
189021 CFR 211.165(e)Test methods
202821 CFR 211.192Extent of discrepancy, failure investigations
203121 CFR 211.194(a)Complete test data included in records
21423FDCA 503B(b)(2)(A)Outsourcing facility, compounded drug report during registration
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general