FDA Inspection
PARI Respiratory Equipment, Inc.PARI Respiratory Equipment, Inc. – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns PARI Respiratory Equipment, Inc., with an inspection on August 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 96291182-71d7-41d5-aa26-9fc0ba983f9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061342
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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Other FDA inspections of PARI Respiratory Equipment, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | Not classified | Baltimore District Office | |
| February 16, 2018 | Not classified | Baltimore District Office | |
| November 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for PARI Respiratory Equipment, Inc.
- FDA Inspection 1321230 - 2026-05-22
- FDA Inspection 1089467 - 2018-02-16
- FDA Inspection 947314 - 2015-11-03
- FDA Inspection 825399 - 2013-03-14
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