FDA Inspection
Continental Medical Labs, Inc.Continental Medical Labs, Inc. – FDA Inspection, Feb 8, 2013
Record Details
This FDA Inspection record concerns Continental Medical Labs, Inc., with an inspection on February 8, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 8, 2013
- Product Type
- Devices
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ID · de689720-99f0-48b3-94ca-3cc4d3bfdc77
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 818223
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Continental Medical Labs, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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