FDA Inspection 1035768 — Shivkamini Somasundaram, M.D.
The FDA completed an inspection of Shivkamini Somasundaram, M.D. on Dec 18, 2017 in Westerville, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 18, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Westerville, OH (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |