FDA Inspection
Izun Pharmaceuticals CorporationIzun Pharmaceuticals Corporation – FDA Inspection, Nov 29, 2017
Record Details
This FDA Inspection record concerns Izun Pharmaceuticals Corporation, with an inspection on November 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b2e1ca10-6be2-4ab7-badd-a15f948e83ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036992
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Izun Pharmaceuticals Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Izun Pharmaceuticals Corporation
- FDA Inspection 1167954 - 2022-04-11
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