FDA Inspection
Thomas ZellersThomas Zellers – FDA Inspection, Mar 20, 2009
Record Details
This FDA Inspection record concerns Thomas Zellers, with an inspection on March 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thomas Zellers
- Inspection Date
- March 20, 2009
- Product Type
- Devices
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ID · c3cc301f-ee3a-43f7-b6af-b3ae699ebb5c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 572686
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(4)Investigator record of protocol deviations inadequate
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
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