FDA Inspection 1160902 — Datascope Corp.
The FDA completed an inspection of Datascope Corp. on Jan 21, 2022 in Wayne, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 21, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Wayne, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 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 |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |