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967221

Calmo Manufacturing, Inc — FEI 3007621443

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 22, 2016
Fiscal Year
2016
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))
  • 1100545 (VAI Fri Aug 23 2019 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
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
202721 CFR 211.192Investigations of discrepancies, failures
363221 CFR 211.170(b)Annual visual exams of drug products