FDA Inspection 700722 — ZOLL Circulation, Inc.
The FDA completed an inspection of ZOLL Circulation, Inc. on Dec 14, 2010 in San Jose, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |