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1200721

kdc/one Chatsworth, Inc. — FEI 1000519695

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 24, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chatsworth, CA (United States)

Facility

Other inspections at this facility

  • 1191646 (NAI Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116865 (VAI Mon Feb 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053774 (VAI Fri May 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045490 (NAI Wed Feb 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956731 (VAI Fri Jan 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
194321 CFR 211.180(e)(1)Review of representative number of batches
197821 CFR 211.182Personnel dating/signing equipment log
241921 CFR 211.198(a)Complaint Handling Procedure
434021 CFR 211.142Written warehousing procedures established/followed
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action