Atlas

Form 483

Portland Sandwich Co. Form 483, 2016-01-12

FDA issued a Form 483 to Portland Sandwich Co. on 2016-01-12 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Portland Sandwich Co. · Portland, United States · Issued January 12, 2016

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.

12 Jan 2016
21 CFR 123.8(a)(2)

Ongoing verification - complaints, calibration records

Cited by Jonathan T Little

12 Jan 2016
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Jonathan T Little

Inspected site

PSPortland Sandwich Co.Portland, United States

Inspection team

JTJonathan T Little

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.8(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)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