FDA Inspection 596382 — Cath-Labs Corp.
The FDA completed an inspection of Cath-Labs Corp. on July 10, 2009 in Hackensack, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hackensack, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2276 | 21 CFR 820.20(b)(1) | Responsibility, authority and independence |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |