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1057630

Ultra Seal Corporation — FEI 1317759

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 29, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Paltz, NY (United States)

Facility

Other inspections at this facility

  • 1263334 (NAI Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229281 (NAI Thu May 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1228761 (NAI Mon Feb 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218129 (VAI Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1157142 (OAI Fri Nov 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
434221 CFR 211.142(b)Storage under appropriate conditions