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660994

Kenvue Brands LLC — FEI 2510184

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 30, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Washington, PA (United States)

Facility

Other inspections at this facility

  • 1181517 (NAI Fri Oct 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1142303 (NAI Mon May 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005463 (NAI Fri Dec 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939726 (NAI Fri Aug 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 924068 (VAI Wed May 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
122721 CFR 211.67(c)Cleaning/maintenance records not kept
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
191421 CFR 211.166(a)Lack of written stability program
197821 CFR 211.182Personnel dating/signing equipment log
202721 CFR 211.192Investigations of discrepancies, failures
203421 CFR 211.194(d)Laboratory equipment calibration records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
430721 CFR 211.80(d)Status of Each Lot Identified
431821 CFR 211.84(d)(4)Microscopic Exam of Components
432221 CFR 211.101(d)Component release checked by 2nd person
432521 CFR 211.110(a)Control procedures fail to include the following
434421 CFR 211.160(b)(1)Sampling and testing procedures described
434921 CFR 211.160(b)(2)In-process samples representative, identified properly
438921 CFR 211.198(a)Procedures to be written and followed