FDA Inspection
Capsule Tech, IncCapsule Tech, Inc – FDA Inspection, Oct 20, 2016
Record Details
This FDA Inspection record concerns Capsule Tech, Inc, with an inspection on October 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d86ae548-314a-484e-905b-fca95c75ceec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989624
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Capsule Tech, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2018 | Not classified | New England District Office | |
| October 20, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Capsule Tech, Inc
- FDA Inspection 1109050 - 2018-10-26
- FDA Inspection 989623 - 2016-10-20
- FDA Inspection 866410 - 2014-02-18
- FDA Inspection 730415 - 2011-06-16
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