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1218129

Ultra Seal Corporation — FEI 1317759

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2023
Fiscal Year
2023
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))
  • 1157142 (OAI Fri Nov 19 2021 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
104921 CFR 211.22(a)Approve or reject components, products
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
434221 CFR 211.142(b)Storage under appropriate conditions