FDA Inspection
Meril Endo Surgery Pvt. Ltd.Meril Endo Surgery Pvt. Ltd. – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns Meril Endo Surgery Pvt. Ltd., with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9988ab5c-5c3d-437c-b8be-2bf8a21d1be3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195565
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
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