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FDA Inspection
•ZOLL Circulation, Inc.•June 21, 2012

ZOLL Circulation, Inc. – FDA Inspection, Jun 21, 2012

Record Details

This FDA Inspection record concerns ZOLL Circulation, Inc., with an inspection on June 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
ZOLL Circulation, Inc.
Inspection Date
June 21, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · ea033415-c7c2-4a1f-ab1d-8a583e9b21da

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
784939
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

2
  1. 21 CFR 803.50(a)(1)Report of Death or Serious Injury
  2. 21 CFR 820.30(c)Design input - documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of ZOLL Circulation, Inc.

6
DateClassificationOfficeProject area
February 13, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
February 13, 2024VAICenter for Devices and Radiological HealthProject Evaluation: Devices
November 9, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
August 12, 2014NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
August 15, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
View all 6 other inspections on the company page
Other documents for ZOLL Circulation, Inc.
  • FDA Inspection 1230860 - 2024-02-13
  • FDA Inspection 1229961 - 2024-02-13
  • FDA Inspection 1031344 - 2017-11-09
  • FDA Inspection 890920 - 2014-08-12
  • FDA Inspection 793844 - 2012-08-15

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