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1071500

Allermed Laboratories, Inc. — FEI 1000098920

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 12, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1228221 (VAI Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022877 (VAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933388 (VAI Mon Jul 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843070 (VAI Mon Aug 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749646 (VAI Tue Sep 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls