FDA Inspection
Zoll Medical CorporationZoll Medical Corporation – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns Zoll Medical Corporation, with an inspection on November 10, 2016, issued by the Minneapolis District Office, covering medical devices & rad health.
- Company
- Zoll Medical Corporation
- Inspection Date
- November 10, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · d0441edd-24c0-4351-9b22-422ebf8b6645
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992925
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zoll Medical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | Not classified | Minneapolis District Office | Compliance: Medical Devices |
| June 13, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 11, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zoll Medical Corporation
- FDA Inspection 1229838 - 2024-09-13
- FDA Inspection 1171958 - 2022-06-13
- FDA Inspection 800735 - 2012-09-18
- FDA Inspection 712206 - 2011-01-11
- FDA Inspection 683406 - 2010-12-17
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