Form 483

Medi Manufacturing Inc Form 483, 2010-03-12

FDA issued a Form 483 to Medi Manufacturing Inc on 2010-03-12 with 4 public-safe observations.

483· Form 483 issued4 observations

Medi Manufacturing Inc · Whitsett, United States · Issued March 12, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

12 Mar 2010
21 CFR 820.60

Identification procedures, Lack of or inadequate procedures

Cited by Babatunde D Babalola

12 Mar 2010
21 CFR 820.75(a)

Documentation

Cited by Babatunde D Babalola

12 Mar 2010
21 CFR 820.198(a)

General

Cited by Babatunde D Babalola

12 Mar 2010
21 CFR 820.250(a)

Appropriateness

Cited by Babatunde D Babalola

Inspected site

MMMedi Manufacturing IncWhitsett, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.250(a)Cited across public-safe Form 483 observations1x
21 CFR 820.60Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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