FDA Inspection
Blephex, LLCBlephex, LLC – FDA Inspection, Nov 19, 2025
Record Details
This FDA Inspection record concerns Blephex, LLC, with an inspection on November 19, 2025, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · ec5ce89b-b856-42df-9080-01f038fb07ff
Inspection Facts
- Inspection number
- 1283430
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Blephex, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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