Home / Inspections / 1175495

1175495

Renu Laboratories, Inc. — FEI 3003263206

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Warminster, PA (United States)

Facility

Other inspections at this facility

  • 1254082 (NAI Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026865 (VAI Tue Sep 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 760599 (VAI Wed Dec 28 2011 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
144821 CFR 211.111Establishment of time limitations
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191221 CFR 211.166(a)Written program not followed
241921 CFR 211.198(a)Complaint Handling Procedure