FDA Inspection 717161 — ZOLL Medical Corporation
The FDA completed an inspection of ZOLL Medical Corporation on March 18, 2011 in Chelmsford, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 4228 | 21 CFR 821.25(a) | Written tracking program |
| 4252 | 21 CFR 821.25(c)(3) | Quality assurance procedures: 6-month & annual audits |
| 648 | 21 CFR 803.18(e) | MDR not evaluated per 820.198 |