Atlas

Form 483

Pinnacle Labs International, Inc. Form 483, 2016-09-21

FDA issued a Form 483 to Pinnacle Labs International, Inc. on 2016-09-21 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Pinnacle Labs International, Inc. · Upland, United States · Issued September 21, 2016

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.

21 Sep 2016
21 CFR 111.35(b)(4)

Records - equipment; calibrations, inspections, checks

Cited by Marcus F Yambot

21 Sep 2016
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Marcus F Yambot

21 Sep 2016
21 CFR 111.110(c)

Quality control operations - tests, examinations; results

Cited by Marcus F Yambot

Inspected site

PLPinnacle Labs International, Inc.Upland, United States

Inspection team

MFMarcus F Yambot

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.110(c)Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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