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1269791

Geri-Care Pharmaceuticals Corp. — FEI 2435388

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 5, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lakewood, NJ (United States)

Facility

Other inspections at this facility

  • 1085751 (NAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027069 (NAI Thu Sep 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886331 (NAI Thu Jun 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793414 (NAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 705311 (NAI Thu Jan 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
110521 CFR 211.22(d)Procedures not in writing, fully followed
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
363221 CFR 211.170(b)Annual visual exams of drug products