Atlas

Form 483

PETNET Solutions, Inc. Form 483, 2016-05-31

FDA issued a Form 483 to PETNET Solutions, Inc. on 2016-05-31 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

PETNET Solutions, Inc. · Culver City, United States · Issued May 31, 2016

Overview

  • 4 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.

31 May 2016
21 CFR 212.20(c)

Initial specifications, methods, processes

Cited by Roger F Zabinski

31 May 2016
21 CFR 212.60(f)

Documenting procedures

Cited by Roger F Zabinski

31 May 2016
21 CFR 11

Electronic records

Cited by Roger F Zabinski

31 May 2016
21 CFR 212.20(c)

Specifications and processes

Cited by Roger F Zabinski

Inspected site

PSPETNET Solutions, Inc.Culver City, United States

Inspection team

RFRoger F Zabinski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.20(c)Cited across public-safe Form 483 observations2x
21 CFR 11Cited across public-safe Form 483 observations1x
21 CFR 212.60(f)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