Atlas

Form 483

Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara Form 483, 2010-10-15

FDA issued a Form 483 to Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara on 2010-10-15 with 2 public-safe observations.

483· Form 483 issued2 observations

Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara · Woburn, United States · Issued October 15, 2010

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.

15 Oct 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Margaret E Walsh

15 Oct 2010
21 CFR 211.192

Quality control unit review of records

Cited by Margaret E Walsh

Inspected site

RHRotech Healthcare Inc.d/b/a/ First Community Care of NiagaraWoburn, United States

Inspection team

MEMargaret E Walsh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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