FDA Inspection
Innovative Sterilization Technologies LLCInnovative Sterilization Technologies LLC – FDA Inspection, Aug 13, 2015
Record Details
This FDA Inspection record concerns Innovative Sterilization Technologies LLC, with an inspection on August 13, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 13, 2015
- Product Type
- Devices
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ID · d5d19010-965e-4289-937d-283401356bb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 937368
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Innovative Sterilization Technologies LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Innovative Sterilization Technologies LLC
- FDA Inspection 1246872 - 2024-08-01
- FDA Inspection 1160547 - 2022-01-13
- FDA Inspection 1009415 - 2017-04-12
- FDA Inspection 950174 - 2015-11-04
- FDA Inspection 907935 - 2014-12-22
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