FDA Inspection
Don Tay Industries Ltd.Don Tay Industries Ltd. – FDA Inspection, Nov 5, 2008
Record Details
This FDA Inspection record concerns Don Tay Industries Ltd., with an inspection on November 5, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Don Tay Industries Ltd.
- Inspection Date
- November 5, 2008
- Product Type
- Devices
View Company Profile
ID · cff01b82-6023-42e3-93b3-7236bc861baf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 546290
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.20(b)(2)Resources
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20Management responsibility
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
- 21 CFR 820.181(b)DMR production process specifications
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Don Tay Industries Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Don Tay Industries Ltd.
- FDA Inspection 622827 - 2009-10-23
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