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Form 483

Marietta Corporation Form 483, 2015-06-15

FDA issued a Form 483 to Marietta Corporation on 2015-06-15 with 16 public-safe observations.

483· Form 483 issuedHuman Drugs16 observations

Marietta Corporation · Cortland, United States · Issued June 15, 2015

Overview

  • 16 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.

15 Jun 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sasha M Latonis

15 Jun 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sasha M Latonis

15 Jun 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sasha M Latonis

15 Jun 2015
21 CFR 211.166(a)

Written program not followed

Cited by Sasha M Latonis

15 Jun 2015
21 CFR 211.166(a)

Written program not followed

Cited by Sasha M Latonis

Inspected site

MCMarietta CorporationCortland, United States

Inspection team

SMSasha M Latonis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations4x
21 CFR 211.166(a)Cited across public-safe Form 483 observations4x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x

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 16 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