FDA Inspection
Surgical Innovations LtdSurgical Innovations Ltd – FDA Inspection, Jul 6, 2017
Record Details
This FDA Inspection record concerns Surgical Innovations Ltd, with an inspection on July 6, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d8f50bcf-c69a-405e-857e-464675b254b3
Inspection Facts
- Inspection number
- 1018231
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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