Atlas

Form 483

Ulka Vaishampayam, M.D.,Clinical Investigator Form 483, 2016-12-23

FDA issued a Form 483 to Ulka Vaishampayam, M.D.,Clinical Investigator on 2016-12-23 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Ulka Vaishampayam, M.D.,Clinical Investigator · Detroit, United States · Issued December 23, 2016

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

23 Dec 2016
21 CFR 312.60

FD-1572, protocol compliance

Cited by Neali H Lucas

23 Dec 2016
21 CFR 50.25(a)(2)

Reasonably foreseeable risks or discomforts

Cited by Neali H Lucas

Inspected site

UVUlka Vaishampayam, M.D.,Clinical InvestigatorDetroit, United States

Inspection team

NHNeali H Lucas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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