FDA Inspection
Duckworth & Kent, Ltd.Duckworth & Kent, Ltd. – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Duckworth & Kent, Ltd., with an inspection on May 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 65eb5acb-7f5b-44ea-9c30-8c3b548eea2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1052699
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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