Atlas

Form 483

Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara Form 483, 2015-05-15

FDA issued a Form 483 to Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara on 2015-05-15 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Rotech Healthcare Inc.d/b/a/ First Community Care of Niagara · Woburn, United States · Issued May 15, 2015

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.

15 May 2015
21 CFR 211.160(b)(4)

Written calibration procedures

Cited by Erik W Koester, Stacey S Degarmo

15 May 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Erik W Koester, Stacey S Degarmo

Inspected site

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

Inspection team

EWErik W Koester
SSStacey S Degarmo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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