FDA Inspection
Lee Memorial Health System IRCLee Memorial Health System IRC – FDA Inspection, Aug 20, 2010
Record Details
This FDA Inspection record concerns Lee Memorial Health System IRC, with an inspection on August 20, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 20, 2010
- Product Type
- Drugs
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ID · e194ce82-847c-4c73-a826-f794a561bbb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676607
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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Other FDA inspections of Lee Memorial Health System IRC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Lee Memorial Health System IRC
- FDA Inspection 981963 - 2016-08-10
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