FDA Inspection
iCRco, Inc.iCRco, Inc. – FDA Inspection, Sep 15, 2016
Record Details
This FDA Inspection record concerns iCRco, Inc., with an inspection on September 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- iCRco, Inc.
- Inspection Date
- September 15, 2016
- Product Type
- Devices
View Company Profile
ID · 6523f99c-a879-4cf6-802d-47b1d5d670eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986611
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of iCRco, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | NAI | Los Angeles District Office | Postmarket Assurance: Devices |
| July 1, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for iCRco, Inc.
- FDA Inspection 1326762 - 2026-07-17
- FDA Inspection 1173371 - 2022-07-01
- FDA Inspection 1049249 - 2018-04-20
- FDA Inspection 825866 - 2013-03-28
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