Atlas

Form 483

SRI Healthcare, Llc Form 483, 2012-06-07

FDA issued a Form 483 to SRI Healthcare, Llc on 2012-06-07 with 2 public-safe observations.

483· Form 483 issued2 observations

SRI Healthcare, Llc · Mason, United States · Issued June 7, 2012

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.

7 Jun 2012
21 CFR 820.70(g)(1)

Maintenance schedule, Lack of or inadequate schedule

Cited by Christine E Kelley

7 Jun 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Christine E Kelley

Inspected site

SHSRI Healthcare, LlcMason, United States

Inspection team

CEChristine E Kelley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(g)(1)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