Atlas

Form 483

Vijay S. Patel MD Form 483, 2011-08-19

FDA issued a Form 483 to Vijay S. Patel MD on 2011-08-19 with 2 public-safe observations.

483· Form 483 issued2 observations

Vijay S. Patel MD · Augusta, United States · Issued August 19, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

19 Aug 2011
21 CFR 312.60

FD-1572, protocol compliance

Cited by Nicole M Bell, John D Lloyd

19 Aug 2011
21 CFR 312.66

Unanticipated problems

Cited by Nicole M Bell, John D Lloyd

Inspected site

VSVijay S. Patel MDAugusta, United States

Inspection team

NMNicole M Bell
JDJohn D Lloyd

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.66Cited 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