FDA Inspection
Razel Scientific Instruments, Inc.Razel Scientific Instruments, Inc. – FDA Inspection, Aug 2, 2012
Record Details
This FDA Inspection record concerns Razel Scientific Instruments, Inc., with an inspection on August 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 2, 2012
- Product Type
- Devices
View Company Profile
ID · 3702d6ab-0af6-4525-9bf1-34acbed72168
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793281
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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