FDA Inspection
21st Century Scientific Inc21st Century Scientific Inc – FDA Inspection, Sep 12, 2018
Record Details
This FDA Inspection record concerns 21st Century Scientific Inc, with an inspection on September 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5aa8c4cb-1c5e-4de4-913d-9b0124fcb399
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1066564
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
4- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.72(b)Remedial action
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of 21st Century Scientific Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 21st Century Scientific Inc
- FDA Inspection 1151898 - 2021-09-17
- FDA Inspection 1007072 - 2017-03-21
- FDA Inspection 736167 - 2011-07-13
- FDA Inspection 547939 - 2008-10-29
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