FDA Inspection
Ever CorporationEver Corporation – FDA Inspection, Feb 8, 2017
Record Details
This FDA Inspection record concerns Ever Corporation, with an inspection on February 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6e12f5e3-724c-422d-b7f3-bfbdeb5e06ce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001829
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR Procedures
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