FDA Inspection
Cath-Labs Corp.Cath-Labs Corp. – FDA Inspection, Jul 10, 2009
Record Details
This FDA Inspection record concerns Cath-Labs Corp., with an inspection on July 10, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cath-Labs Corp.
- Inspection Date
- July 10, 2009
- Product Type
- Devices
View Company Profile
ID · aaee4e29-2386-4b7f-854a-eec7dee92678
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 596382
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(b)(1)Responsibility, authority and independence
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.181(a)DMR device specifications
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