FDA Inspection
The Kilroy CompanyThe Kilroy Company – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns The Kilroy Company, with an inspection on September 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Kilroy Company
- Inspection Date
- September 11, 2009
- Product Type
- Devices
View Company Profile
ID · 93ed0cab-5f08-4b33-af24-cb49409e4a7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606924
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
17- 21 CFR 820.80(e)Documentation
- 21 CFR 820.80(e)(5)Equipment
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Showing 10 of 17 citations.
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Other FDA inspections of The Kilroy Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 7, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for The Kilroy Company
- FDA Inspection 839722 - 2011-07-10
- FDA Inspection 538058 - 2009-01-07
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