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Form 483

Pro Pac Labs, LLC dba MeriCal Utah Form 483, 2018-10-23

FDA issued a Form 483 to Pro Pac Labs, LLC dba MeriCal Utah on 2018-10-23 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Pro Pac Labs, LLC dba MeriCal Utah · Ogden, United States · Issued October 23, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

23 Oct 2018
21 CFR 111.303

Written procedures - laboratory operations

Cited by Felicia M Orlando

23 Oct 2018
21 CFR 111.77(a)

Specifications not met - reject, quality control

Cited by Felicia M Orlando

Inspected site

PPPro Pac Labs, LLC dba MeriCal UtahOgden, United States

Inspection team

FMFelicia M Orlando

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.303Cited across public-safe Form 483 observations1x
21 CFR 111.77(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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