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713920

Advanced Skin Technologies, Inc. — FEI 2520333

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 16, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bernville, PA (United States)

Facility

Other inspections at this facility

  • 1025342 (VAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 877793 (NAI Fri May 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 749192 (NAI Tue Oct 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710382 (NAI Wed Feb 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 635548 (OAI Thu Jan 07 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
122721 CFR 211.67(c)Cleaning/maintenance records not kept
136121 CFR 211.100(a)Absence of Written Procedures
149521 CFR 211.122(a)Written procedures describing in detail
176721 CFR 211.137(a)Expiration date lacking
178721 CFR 211.80(a)Procedures To Be in Writing
188321 CFR 211.165(a)Testing and release for distribution
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed
900121 CFR 211.22(a)Lack of quality control unit