FDA Inspection
Stericycle IncStericycle Inc – FDA Inspection, Feb 12, 2024
Record Details
This FDA Inspection record concerns Stericycle Inc, with an inspection on February 12, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6b47ddfc-2911-4d5d-9492-ff0dff7a3e2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1231682
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stericycle Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2025 | VAI | Chicago District Office | Compliance: Medical Devices |
| February 27, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 22, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 12, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stericycle Inc
- FDA Inspection 1261654 - 2025-02-18
- FDA Inspection 1119516 - 2020-02-27
- FDA Inspection 782981 - 2012-05-22
- FDA Inspection 555705 - 2009-01-12
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