FDA Inspection
Gelflex LaboratoriesGelflex Laboratories – FDA Inspection, Nov 30, 2017
Record Details
This FDA Inspection record concerns Gelflex Laboratories, with an inspection on November 30, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 914f4d82-d192-4950-9dc7-27673166940e
Inspection Facts
- Inspection number
- 1032353
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Gelflex Laboratories
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Gelflex Laboratories
- FDA Inspection 916761 - 2015-01-30
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