Company
United StatesAdvanced Sterilization Products, Irvine, CA – FDA Inspections
Inspection records and compliance data for Advanced Sterilization Products in Irvine, California. 7 FDA inspections on record (2 OAI), last inspected August 11, 2017.
Company Profile
This profile covers Advanced Sterilization Products based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 28, 2009. Last inspected August 11, 2017.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design output - Lack of or inadequate procedures1 inspection
- Design validation - simulated testing1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 11, 2017 | Not classified | Medical Devices & Rad Health | 1034571 |
| October 28, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 948179 |
| November 15, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 853825 |
| June 21, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 788386 |
| December 17, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 702976 |
| June 16, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 669654 |
| September 28, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 616347 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Advanced Sterilization Products
FEI Number
3003662624
Address
33 Technology Dr, Irvine, California 92618, United States
Country
United States
ID: 87dc005d-e389-4761-a347-07c3d81ef54b