FDA Inspection
Deltex Medical LimitedDeltex Medical Limited – FDA Inspection, Jul 23, 2015
Record Details
This FDA Inspection record concerns Deltex Medical Limited, with an inspection on July 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Deltex Medical Limited
- Inspection Date
- July 23, 2015
- Product Type
- Devices
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ID · e28be4ec-55fc-4d08-94f0-8ad018d41575
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 938194
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Deltex Medical Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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