FDA Inspection 850635 — Pattanam D. Srinivasan, MD
The FDA completed an inspection of Pattanam D. Srinivasan, MD on September 27, 2013 in Kokomo, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 28 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 27, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Kokomo, IN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14513 | 21 CFR 812.2(c)(3) | Needs IDE; diagnostic device exemption conditions not met |
| 14520 | 21 CFR 812.36(d) | No FDA approval for treatment IDE |
| 14521 | 21 CFR 812.36(e) | No IRB approval for treatment use |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 3034 | 21 CFR 812.150(a)(6) | Investigator final report |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |
| 7383 | 21 CFR 50.25(b)(6) | Number of subjects in study |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |
| 7385 | 21 CFR 50.25(b)(3) | Possible additional costs to the subject |
| 7386 | 21 CFR 50.25(b)(4) | Consequences of withdrawing |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7657 | 21 CFR 50.25(b)(5) | Significant new findings |
| 7658 | 21 CFR 50.25(b)(2) | Termination by investigator |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |
| 7665 | 21 CFR 50.20 | Exculpatory language, waiving of rights |