FDA Inspection 729955 — ZOLL Medical Corporation
The FDA completed an inspection of ZOLL Medical Corporation on June 7, 2011 in Chelmsford, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4248 | 21 CFR 821.25(b) | Records not current |
| 4252 | 21 CFR 821.25(c)(3) | Quality assurance procedures: 6-month & annual audits |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |