FDA Inspection
Gesco Healthcare Private LimitedGesco Healthcare Private Limited – FDA Inspection, Apr 6, 2017
Record Details
This FDA Inspection record concerns Gesco Healthcare Private Limited, with an inspection on April 6, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 6, 2017
- Product Type
- Medical Devices & Rad Health
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ID · caab27b6-dfde-4512-a122-1e2eaa033a7d
Inspection Facts
- Inspection number
- 1008952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
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