FDA Inspection
Edge Biologicals IncEdge Biologicals Inc – FDA Inspection, Sep 16, 2011
Record Details
This FDA Inspection record concerns Edge Biologicals Inc, with an inspection on September 16, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Edge Biologicals Inc
- Inspection Date
- September 16, 2011
- Product Type
- Devices
View Company Profile
ID · 46526fc1-4ce2-4113-b836-7190cd09fa37
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 745047
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.130Packaging
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Edge Biologicals Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2026 | Not classified | New Orleans District Office | |
| November 22, 2024 | OAI | New Orleans District Office | Compliance: Medical Devices |
| April 4, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 29, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Edge Biologicals Inc
- FDA Inspection 1300804 - 2026-01-08
- FDA Inspection 1256286 - 2024-11-22
- FDA Inspection 1201822 - 2023-04-04
- FDA Inspection 1044506 - 2018-03-15
- FDA Inspection 911616 - 2015-01-29
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