FDA Inspection
Neocis Inc.Neocis Inc. – FDA Inspection, Nov 2, 2018
Record Details
This FDA Inspection record concerns Neocis Inc., with an inspection on November 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e10c80ae-2e82-4fa8-9f47-1548306d2d79
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1071155
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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Other FDA inspections of Neocis Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 5, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Neocis Inc.
- FDA Inspection 1242470 - 2024-06-28
- FDA Inspection 1177490 - 2022-08-11
- FDA Inspection 1177489 - 2022-08-05
- FDA Inspection 1167404 - 2022-02-24
- FDA Inspection 1112461 - 2019-12-11
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