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FDA Inspection
•PARI Respiratory Equipment, Inc.•November 3, 2015

PARI Respiratory Equipment, Inc. – FDA Inspection, Nov 3, 2015

Record Details

This FDA Inspection record concerns PARI Respiratory Equipment, Inc., with an inspection on November 3, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
PARI Respiratory Equipment, Inc.
Inspection Date
November 3, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 5329ee27-7ea6-4dbc-ad27-04200567110e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
947314
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.198(c)Investigation of device failures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PARI Respiratory Equipment, Inc.

4
DateClassificationOfficeProject area
May 22, 2026Not classifiedBaltimore District Office
August 3, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
February 16, 2018Not classifiedBaltimore District Office
March 14, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for PARI Respiratory Equipment, Inc.
  • FDA Inspection 1321230 - 2026-05-22
  • FDA Inspection 1061342 - 2018-08-03
  • FDA Inspection 1089467 - 2018-02-16
  • FDA Inspection 825399 - 2013-03-14

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