FDA Inspection
Ruwanti Gunawardane, M.D.Ruwanti Gunawardane, M.D. – FDA Inspection, May 16, 2016
Record Details
This FDA Inspection record concerns Ruwanti Gunawardane, M.D., with an inspection on May 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ruwanti Gunawardane, M.D.
- Inspection Date
- May 16, 2016
- Product Type
- Drugs
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ID · b57fd0c7-5829-4bda-8aea-4d3ccc7a1a01
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 991421
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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