FDA Inspection
Benjamin Biomedical, Inc.Benjamin Biomedical, Inc. – FDA Inspection, Nov 2, 2012
Record Details
This FDA Inspection record concerns Benjamin Biomedical, Inc., with an inspection on November 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Benjamin Biomedical, Inc.
- Inspection Date
- November 2, 2012
- Product Type
- Devices
View Company Profile
ID · f6aa89f4-b50d-4b42-9277-12f292efc9ad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 806750
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Benjamin Biomedical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Benjamin Biomedical, Inc.
- FDA Inspection 837456 - 2013-06-19
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