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Form 483

Digestive Care Inc Form 483, 2012-03-02

FDA issued a Form 483 to Digestive Care Inc on 2012-03-02 with 2 public-safe observations.

483· Form 483 issued2 observations

Digestive Care Inc · Bethlehem, United States · Issued March 2, 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.

2 Mar 2012
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by James M Mason

2 Mar 2012
21 CFR 211.63

Equipment Design, Size and Location

Cited by James M Mason

Inspected site

DCDigestive Care IncBethlehem, United States

Inspection team

JMJames M Mason

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited 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 2 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