FDA Inspection
Dechoker, LLCDechoker, LLC – FDA Inspection, May 1, 2019
Record Details
This FDA Inspection record concerns Dechoker, LLC, with an inspection on May 1, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a9436273-c88a-4d98-b21f-f20573390dc4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088246
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Dechoker, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2023 | Not classified | Denver District Office | |
| May 26, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 26, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dechoker, LLC
- FDA Inspection 1221003 - 2023-10-24
- FDA Inspection 1209065 - 2023-05-26
- FDA Inspection 1136057 - 2021-02-26
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