Form 483

Ivy City Smokehouse, Inc Form 483, 2019-08-14

FDA issued a Form 483 to Ivy City Smokehouse, Inc on 2019-08-14 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Ivy City Smokehouse, Inc · Washington, United States · Issued August 14, 2019

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 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 Aug 2019
21 CFR 123.6(c)(2)

Critical control points

Cited by Mark A Jackson

14 Aug 2019
21 CFR 123.6(c)(3)

Critical limits

Cited by Mark A Jackson

14 Aug 2019
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Mark A Jackson

14 Aug 2019
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Mark A Jackson

14 Aug 2019
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Mark A Jackson

Inspected site

ICIvy City Smokehouse, IncWashington, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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