FDA Inspection
Glottal Enterprises Inc.Glottal Enterprises Inc. – FDA Inspection, Oct 18, 2012
Record Details
This FDA Inspection record concerns Glottal Enterprises Inc., with an inspection on October 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Glottal Enterprises Inc.
- Inspection Date
- October 18, 2012
- Product Type
- Devices
View Company Profile
ID · 8c537f0c-e8c8-4fcb-9057-1c42c13ae42c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 804076
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Glottal Enterprises Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| March 6, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Glottal Enterprises Inc.
- FDA Inspection 1251914 - 2024-10-17
- FDA Inspection 1120569 - 2020-03-06
- FDA Inspection 996504 - 2016-12-13
- FDA Inspection 852562 - 2013-10-09
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