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Form 483

PETNET Solutions, Inc. Form 483, 2013-06-26

FDA issued a Form 483 to PETNET Solutions, Inc. on 2013-06-26 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

PETNET Solutions, Inc. · Denver, United States · Issued June 26, 2013

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.

26 Jun 2013
21 CFR 212.10

Lack Adequate Resources, Facilities, Equipment.

Cited by Erika V Butler

26 Jun 2013
21 CFR 212.50

Adequate controls (general)

Cited by Erika V Butler

26 Jun 2013
21 CFR 212.60(e)

Equipment

Cited by Erika V Butler

Inspected site

PSPETNET Solutions, Inc.Denver, United States

Inspection team

EVErika V Butler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.10Cited across public-safe Form 483 observations1x
21 CFR 212.50Cited across public-safe Form 483 observations1x
21 CFR 212.60(e)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