FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Oct 18, 2016
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on October 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · 6bc72c7f-ec10-44b5-9b7a-a59325b4fa48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992399
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of ZOLL Medical Corporation
14| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| August 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 8, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ZOLL Medical Corporation
- FDA Inspection 1246565 - 2025-04-15
- FDA Inspection 982649 - 2016-08-26
- FDA Inspection 966609 - 2016-04-08
- FDA Inspection 900180 - 2014-08-07
- FDA Inspection 875284 - 2014-04-18
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