Form 483

The Stamford Hospital Form 483, 2010-12-15

FDA issued a Form 483 to The Stamford Hospital on 2010-12-15 with 3 public-safe observations.

483· Form 483 issued3 observations

The Stamford Hospital · Stamford, United States · Issued December 15, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

15 Dec 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Anthony N Onianwa

15 Dec 2010
21 CFR 606.170(a)

Adverse Reaction- Reports of Investigations

Cited by Anthony N Onianwa

15 Dec 2010
21 CFR 606.171

Biological product deviation report

Cited by Anthony N Onianwa

Inspected site

TSThe Stamford HospitalStamford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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