FDA Inspection
Respire Medical Holdings, LLCRespire Medical Holdings, LLC – FDA Inspection, Aug 15, 2019
Record Details
This FDA Inspection record concerns Respire Medical Holdings, LLC, with an inspection on August 15, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a02d56c6-03c9-45f0-a1eb-6f201ed2d73a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Respire Medical Holdings, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 22, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Respire Medical Holdings, LLC
- FDA Inspection 1182077 - 2022-10-25
- FDA Inspection 1051088 - 2018-05-02
- FDA Inspection 996025 - 2016-11-22
- FDA Inspection 862926 - 2014-01-16
- FDA Inspection 754250 - 2011-11-18
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