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1157142

Ultra Seal Corporation — FEI 1317759

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 19, 2021
Fiscal Year
2022
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))
  • 1057630 (VAI Fri Jun 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
121521 CFR 211.67(b)Written procedures not established/followed
202721 CFR 211.192Investigations of discrepancies, failures