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1046486

Newton Laboratories, Inc. — FEI 1051203

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 30, 2018
Fiscal Year
2018
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))
  • 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))
  • 794399 (VAI Thu Jul 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
204421 CFR 211.196Distribution Record Requirements
262121 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include
439121 CFR 211.180(e)(2)Items to cover on annual reviews