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1069646

Sun Deep Inc. — FEI 1000523173

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2018
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hayward, CA (United States)

Facility

Other inspections at this facility

  • 1275343 (OAI Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895138 (VAI Fri Aug 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 659902 (NAI Tue May 04 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 605403 (NAI Mon Aug 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
189121 CFR 211.165(f)Failing drug products not rejected
191421 CFR 211.166(a)Lack of written stability program
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
457621 CFR 211.192No written record of investigation