FDA Inspection
Advanced Sterilization ProductsAdvanced Sterilization Products – FDA Inspection, Dec 17, 2010
Record Details
This FDA Inspection record concerns Advanced Sterilization Products, with an inspection on December 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2010
- Product Type
- Devices
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ID · 98b5f0c3-d0a4-495d-8495-19706abe6cec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702976
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 803.52(b)(1)Identification of Adverse Event or Product Problem
- 21 CFR 803.52(f)(1)Type of Reportable Event
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.70(i)Validation of changes to automated process software
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.198(e)Maintained
Showing 10 of 13 citations.
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Other FDA inspections of Advanced Sterilization Products
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | Not classified | Los Angeles District Office | |
| October 28, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 15, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 21, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Sterilization Products
- FDA Inspection 1034571 - 2017-08-11
- FDA Inspection 948179 - 2015-10-28
- FDA Inspection 853825 - 2013-11-15
- FDA Inspection 788386 - 2012-06-21
- FDA Inspection 669654 - 2010-06-16
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