FDA Inspection
Steris Applied Sterilization Technologies ULCSteris Applied Sterilization Technologies ULC – FDA Inspection, Nov 21, 2024
Record Details
This FDA Inspection record concerns Steris Applied Sterilization Technologies ULC, with an inspection on November 21, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- November 21, 2024
- Product Type
- Medical Devices & Rad Health
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ID · d29853d3-6c5a-4dfb-bbfb-4e7463a7a49e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1254759
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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Other FDA inspections of Steris Applied Sterilization Technologies ULC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Steris Applied Sterilization Technologies ULC
- FDA Inspection 1273126 - 2025-05-14
- FDA Inspection 1090677 - 2019-04-17
- FDA Inspection 897808 - 2014-09-12
- FDA Inspection 789382 - 2012-06-28
- FDA Inspection 610911 - 2009-08-12
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