FDA Inspection
Crown Delta CorpCrown Delta Corp – FDA Inspection, Mar 4, 2014
Record Details
This FDA Inspection record concerns Crown Delta Corp, with an inspection on March 4, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Crown Delta Corp
- Inspection Date
- March 4, 2014
- Product Type
- Devices
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ID · 4cabbc80-e902-4cdb-933a-5266d3bece58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 866895
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Crown Delta Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 4, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Crown Delta Corp
- FDA Inspection 1192125 - 2022-10-31
- FDA Inspection 1014734 - 2017-04-04
- FDA Inspection 699915 - 2010-11-23
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