FDA Inspection
GHC Healthcare Inc.GHC Healthcare Inc. – FDA Inspection, Apr 20, 2012
Record Details
This FDA Inspection record concerns GHC Healthcare Inc., with an inspection on April 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GHC Healthcare Inc.
- Inspection Date
- April 20, 2012
- Product Type
- Devices
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ID · ae28cebe-7cd5-4d01-9b3d-c4750173266b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779894
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of GHC Healthcare Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GHC Healthcare Inc.
- FDA Inspection 1109701 - 2019-07-15
- FDA Inspection 700363 - 2010-11-17
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