FDA Inspection
Vinyas Innovative Technologies Pvt., Ltd.FDA Inspection 893519 - Vinyas Innovative Technologies Pvt., Ltd. - August 14, 2014
Record Details
This FDA Inspection record concerns Vinyas Innovative Technologies Pvt., Ltd., with an inspection on August 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 14, 2014
- Product Type
- Devices
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ID · ca002d64-fe9e-4af5-b148-78a5a04458e9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 893519
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 803.17Lack of Written MDR Procedures
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