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FDA Inspection
•Pulmonary Filtration Technologies•April 7, 2011

Pulmonary Filtration Technologies – FDA Inspection, Apr 7, 2011

Record Details

This FDA Inspection record concerns Pulmonary Filtration Technologies, with an inspection on April 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Pulmonary Filtration Technologies
Inspection Date
April 7, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · ddf92edb-ceb3-41e4-a2fa-7aae043810c2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
721539
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

2
  1. 21 CFR 820.181DMR - not or inadequately maintained
  2. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pulmonary Filtration Technologies

1
DateClassificationOfficeProject area
February 24, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Pulmonary Filtration Technologies
  • FDA Inspection 959076 - 2016-02-24

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