FDA Inspection 1029757 — ZOLL Medical Corporation
The FDA completed an inspection of ZOLL Medical Corporation on Oct 25, 2017 in Pawtucket, RI. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 25, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pawtucket, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |