Form 483

Lassonde Pappas Inc. Form 483, 2012-03-30

FDA issued a Form 483 to Lassonde Pappas Inc. on 2012-03-30 with 8 public-safe observations.

483· Form 483 issued8 observations

Lassonde Pappas Inc. · Springdale, United States · Issued March 30, 2012

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

30 Mar 2012
21 CFR 111.83(a)

Reserve sample - collect, hold

Cited by Jamie M Bumpas

30 Mar 2012
21 CFR 111.165(d)(1)

Product received - identify

Cited by Jamie M Bumpas

30 Mar 2012
21 CFR 111.410(c)

Packaging, labels - master manufacturing record

Cited by Jamie M Bumpas

30 Mar 2012
21 CFR 111.415

Fill, assemble, package, label - quality

Cited by Jamie M Bumpas

30 Mar 2012
21 CFR 111.455(c)

Hold - mix-up, contamination, deterioration

Cited by Jamie M Bumpas

Inspected site

LPLassonde Pappas Inc.Springdale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.165(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.410(c)Cited across public-safe Form 483 observations1x
21 CFR 111.415Cited across public-safe Form 483 observations1x
21 CFR 111.455(c)Cited across public-safe Form 483 observations1x
21 CFR 111.510Cited across public-safe Form 483 observations1x
21 CFR 111.570(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.83(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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