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1100545

Calmo Manufacturing, Inc — FEI 3007621443

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 23, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Huntington Beach, CA (United States)

Facility

Other inspections at this facility

  • 1213059 (NAI Fri Aug 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967221 (VAI Fri Apr 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 765552 (NAI Wed Jan 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727372 (NAI Mon May 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121 CFR 11Electronic records
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
181021 CFR 211.160(a)Lab controls established, including changes