FDA Inspection 853578 — Datascope Corp.
The FDA completed an inspection of Datascope Corp. on October 17, 2013 in Dayton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |