Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2013-09-27.
At a glance
Inspections
1
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2013 – 27 Sep 2013 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Sep 2013
21 CFR 50.20
Exculpatory language, waiving of rights
Cited by Myra K Casey, Kimberly Y Martin
27 Sep 2013
21 CFR 50.25(a)(1)
Procedures, identification of those which were experimental
Cited by Myra K Casey, Kimberly Y Martin
27 Sep 2013
21 CFR 50.25(a)(1)
Statement of research, purpose, duration of participation
Cited by Myra K Casey, Kimberly Y Martin
27 Sep 2013
21 CFR 50.25(a)(2)
Reasonably foreseeable risks or discomforts
Cited by Myra K Casey, Kimberly Y Martin
27 Sep 2013
21 CFR 50.25(a)(4)
Alternate procedures, courses of treatment
Cited by Myra K Casey, Kimberly Y Martin
Investigators
FDA investigators tied to this site in the record.
Myra K Casey1 insp.
Kimberly Y Martin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.25(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.27(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 50.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 50.25(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.100 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.150(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.2(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.36(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.36(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(4)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.7(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pattanam D. Srinivasan, MD's 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat