FDA Inspection
Biotest Medical CorpBiotest Medical Corp – FDA Inspection, Nov 18, 2010
Record Details
This FDA Inspection record concerns Biotest Medical Corp, with an inspection on November 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biotest Medical Corp
- Inspection Date
- November 18, 2010
- Product Type
- Devices
View Company Profile
ID · 15fce85b-1e81-4ff1-9fb7-21c0138228a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 704675
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biotest Medical Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | Not classified | Office of Inspections and Investigations | |
| May 15, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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