FDA Inspection
D.T. Davis Enterprises Ltd.D.T. Davis Enterprises Ltd. – FDA Inspection, Jan 5, 2010
Record Details
This FDA Inspection record concerns D.T. Davis Enterprises Ltd., with an inspection on January 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- D.T. Davis Enterprises Ltd.
- Inspection Date
- January 5, 2010
- Product Type
- Devices
View Company Profile
ID · e6b723f9-6918-4ec2-bd72-7721cf8f5e43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635556
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(3)Acceptable supplier records
- 21 CFR 820.181(c)DMR QA procedures and specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of D.T. Davis Enterprises Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 3, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for D.T. Davis Enterprises Ltd.
- FDA Inspection 1250965 - 2024-08-29
- FDA Inspection 1166204 - 2022-03-16
- FDA Inspection 1117906 - 2019-12-18
- FDA Inspection 960811 - 2016-02-10
- FDA Inspection 833135 - 2013-05-03
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