FDA Inspection
Katalyst Surgical, LLCKatalyst Surgical, LLC – FDA Inspection, Aug 7, 2017
Record Details
This FDA Inspection record concerns Katalyst Surgical, LLC, with an inspection on August 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fcf0616b-43d6-40d0-9604-b85433e6d095
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Katalyst Surgical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2025 | Not classified | Kansas City District Office | Compliance: Medical Devices |
| March 15, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Katalyst Surgical, LLC
- FDA Inspection 1275730 - 2025-07-16
- FDA Inspection 966433 - 2016-03-15
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