FDA Inspection
DDC Technologies, Inc.DDC Technologies, Inc. – FDA Inspection, Dec 10, 2009
Record Details
This FDA Inspection record concerns DDC Technologies, Inc., with an inspection on December 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DDC Technologies, Inc.
- Inspection Date
- December 10, 2009
- Product Type
- Devices
View Company Profile
ID · 0f21f60b-5654-4e28-84ed-23882f868516
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634321
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DDC Technologies, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| October 22, 2021 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 8, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 28, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2017 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for DDC Technologies, Inc.
- FDA Inspection 1248514 - 2024-09-06
- FDA Inspection 1156159 - 2021-10-22
- FDA Inspection 1115002 - 2020-01-08
- FDA Inspection 1094523 - 2019-06-28
- FDA Inspection 1034820 - 2017-12-07
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