FDA Inspection
P.T. Nipro Indonesia JayaFDA Inspection 1222581 - P.T. Nipro Indonesia Jaya - October 26, 2023
Record Details
This FDA Inspection record concerns P.T. Nipro Indonesia Jaya, with an inspection on October 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1798db1c-2e6e-4ec5-9a48-5b404231a430
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222581
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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