FDA Inspection
IBT Scientific LlcIBT Scientific Llc – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns IBT Scientific Llc, with an inspection on June 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b573ea6b-598c-4155-b8f4-d7636bbfe7d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016806
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of IBT Scientific Llc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 19, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 29, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for IBT Scientific Llc
- FDA Inspection 1298010 - 2025-12-19
- FDA Inspection 1113756 - 2019-12-19
- FDA Inspection 870074 - 2014-03-18
- FDA Inspection 774751 - 2012-03-29
- FDA Inspection 607733 - 2009-08-07
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