FDA Inspection
Technology Delivery Systems IncTechnology Delivery Systems Inc – FDA Inspection, Jun 25, 2013
Record Details
This FDA Inspection record concerns Technology Delivery Systems Inc, with an inspection on June 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 25, 2013
- Product Type
- Devices
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ID · b2be92c8-b43c-40f6-ab98-df7953456ebc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841079
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(c)Management review dates
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Other FDA inspections of Technology Delivery Systems Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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