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Form 483

C-Care LLC Form 483, 2011-11-21

FDA issued a Form 483 to C-Care LLC on 2011-11-21 with 3 public-safe observations.

483· Form 483 issued3 observations

C-Care LLC · Linthicum Heights, United States · Issued November 21, 2011

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.

21 Nov 2011
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Nebil A Oumer

21 Nov 2011
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nebil A Oumer

21 Nov 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nebil A Oumer

Inspected site

CLC-Care LLCLinthicum Heights, United States

Inspection team

NANebil A Oumer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF and 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