FDA Inspection
Phoenix Medical Systems Private LimitedPhoenix Medical Systems Private Limited – FDA Inspection, Aug 7, 2014
Record Details
This FDA Inspection record concerns Phoenix Medical Systems Private Limited, with an inspection on August 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 7, 2014
- Product Type
- Devices
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ID · 86597435-e587-4df4-a787-f1f2739ab98d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894664
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17Lack of Written MDR Procedures
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