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Form 483

Faspac Packaging LP Form 483, 2017-12-14

FDA issued a Form 483 to Faspac Packaging LP on 2017-12-14 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Faspac Packaging LP · Dallas, United States · Issued December 14, 2017

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.

14 Dec 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Scott T Ballard

14 Dec 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Scott T Ballard

14 Dec 2017
21 CFR 211.56(b)

Written sanitation procedures lacking

Cited by Scott T Ballard

14 Dec 2017
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Scott T Ballard

Inspected site

FPFaspac Packaging LPDallas, United States

Inspection team

STScott T Ballard

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited 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