FDA Inspection
DX PRODUCTS LIMITEDDX PRODUCTS LIMITED – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns DX PRODUCTS LIMITED, with an inspection on December 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Bonnie E. Conley (Issuing Officer)
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ID · e85a2c6f-f98a-40e5-9d35-3812b2af09bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034445
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of DX PRODUCTS LIMITED
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2026 | Not classified | Office of Inspections and Investigations | |
| November 3, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DX PRODUCTS LIMITED
- FDA Inspection 1323204 - 2026-05-08
- FDA Inspection 1187483 - 2022-11-03
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