FDA Inspection
Wuxi Contact Electronics Co., Ltd.Wuxi Contact Electronics Co., Ltd. – FDA Inspection, May 16, 2019
Record Details
This FDA Inspection record concerns Wuxi Contact Electronics Co., Ltd., with an inspection on May 16, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 081da603-8407-4577-b04c-20c129810aab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1092639
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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