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728240

BLI International, Inc. — FEI 3001195380

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 13, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Deer Park, NY (United States)

Facility

Other inspections at this facility

  • 1268782 (NAI Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1234201 (NAI Wed Apr 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095698 (NAI Thu Jun 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992510 (VAI Wed Nov 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 927833 (VAI Tue Jun 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126121 CFR 211.68(a)Written calibration / inspection records not kept
180221 CFR 211.84(b)Representative Samples
202821 CFR 211.192Extent of discrepancy, failure investigations
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly