FDA Inspection
Gleemex Inc.Gleemex Inc. – FDA Inspection, Jan 28, 2009
Record Details
This FDA Inspection record concerns Gleemex Inc., with an inspection on January 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gleemex Inc.
- Inspection Date
- January 28, 2009
- Product Type
- Devices
View Company Profile
ID · 39ee9409-6cdd-4c08-bb83-a7993e4577a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 561243
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gleemex Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Gleemex Inc.
- FDA Inspection 710588 - 2011-02-07
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