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FDA Inspection 1106812 — International Sterilization Laboratory, LLC

International Sterilization Laboratory, LLC — FEI 3000203000

The FDA completed an inspection of International Sterilization Laboratory, LLC on October 10, 2019 in Groveland, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 10, 2019
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Groveland, FL (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures

Facility

Other inspections at this facility

  • 1231425 (NAI Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987960 (VAI Thu Sep 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827295 (VAI Wed Apr 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 667070 (VAI Wed Jun 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources