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867839

Alva-Amco Pharmacal Cos Inc. — FEI 1413064

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Niles, IL (United States)

Facility

Other inspections at this facility

  • 1152080 (NAI Thu Sep 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042497 (NAI Wed Feb 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723228 (VAI Wed May 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 671822 (VAI Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636031 (VAI Fri Dec 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
150521 CFR 211.122(d)Label storage access limited to authorized personnel
194221 CFR 211.180(e)Records reviewed annually
219821 CFR 211.186(b)(3)Component Name and Code
359621 CFR 211.122(g)Failure to include one of special control procedures
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up