FDA Inspection
Xtreem Pulse LLCXtreem Pulse LLC – FDA Inspection, Oct 13, 2023
Record Details
This FDA Inspection record concerns Xtreem Pulse LLC, with an inspection on October 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cf8852fb-41d1-4a36-8147-63331520de52
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1220381
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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Other FDA inspections of Xtreem Pulse LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2022 | VAI | Compliance: Devices | |
| June 19, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Xtreem Pulse LLC
- FDA Inspection 1173093 - 2022-06-29
- FDA Inspection 1094170 - 2019-06-19
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