FDA Inspection
CROSSROADS EXTREMITY SYSTEMS LLCCROSSROADS EXTREMITY SYSTEMS LLC – FDA Inspection, Aug 2, 2019
Record Details
This FDA Inspection record concerns CROSSROADS EXTREMITY SYSTEMS LLC, with an inspection on August 2, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ac96e87d-83fa-4e15-9c2e-31ced51555bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098383
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of CROSSROADS EXTREMITY SYSTEMS LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CROSSROADS EXTREMITY SYSTEMS LLC
- FDA Inspection 1178313 - 2022-08-26
- FDA Inspection 984607 - 2016-07-15
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