FDA Inspection
C.L.R. Medicals International, Inc.C.L.R. Medicals International, Inc. – FDA Inspection, Aug 13, 2013
Record Details
This FDA Inspection record concerns C.L.R. Medicals International, Inc., with an inspection on August 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 13, 2013
- Product Type
- Devices
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ID · f4370e23-da04-4395-a873-da8cf71524ff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 844884
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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