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651241

Newton Laboratories, Inc. — FEI 1051203

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Conyers, GA (United States)

Facility

Other inspections at this facility

  • 1152316 (VAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046486 (OAI Fri Mar 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006684 (VAI Wed Mar 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 944175 (NAI Tue Sep 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 914965 (VAI Wed Feb 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
188521 CFR 211.165(b)Microbiological testing
434021 CFR 211.142Written warehousing procedures established/followed
437321 CFR 211.188(b)(7)Actual yield, % of theoretical yield