FDA Inspection 754520 — ZOLL Medical Corporation
The FDA completed an inspection of ZOLL Medical Corporation on Nov 15, 2011 in Chelmsford, MA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4253 | 21 CFR 821.25(d) | Notification of FDA re: non-compliant distributor |