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674159

Kenvue Brands LLC — FEI 2510770

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lititz, PA (United States)

Facility

Other inspections at this facility

  • 1198478 (NAI Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017380 (VAI Fri Jul 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 942887 (VAI Mon Sep 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737103 (NAI Fri Jul 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
120721 CFR 211.65(b)Substances That Come in Contact
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
202821 CFR 211.192Extent of discrepancy, failure investigations
354721 CFR 211.46(b)Equipment for Environmental Control
430321 CFR 211.67(b)Written procedures fail to include
430921 CFR 211.84(c)(2)Containers sampled so as to prevent contamination