Atlas

Form 483

Pattanam D. Srinivasan, MD Form 483, 2013-09-27

FDA issued a Form 483 to Pattanam D. Srinivasan, MD on 2013-09-27 with 28 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health28 observations

Pattanam D. Srinivasan, MD · Kokomo, United States · Issued September 27, 2013

Overview

  • 28 public-safe observations are available for this inspection.
  • 26 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

PDPattanam D. Srinivasan, MDKokomo, United States

Inspection team

MKMyra K Casey
KYKimberly Y Martin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 50.27(a)Cited across public-safe Form 483 observations2x
21 CFR 50.20Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 50.25(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 812.100Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(3)(ii)Cited across public-safe Form 483 observations1x
21 CFR 812.140(d)Cited across public-safe Form 483 observations1x
21 CFR 812.150(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 812.2(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 812.36(d)Cited across public-safe Form 483 observations1x
21 CFR 812.36(e)Cited across public-safe Form 483 observations1x
21 CFR 812.43(c)(4)(i)Cited across public-safe Form 483 observations1x
21 CFR 812.7(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 28 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere