Form 483

Tony's Smoke House & Cannery, Inc. Form 483, 2011-09-28

FDA issued a Form 483 to Tony's Smoke House & Cannery, Inc. on 2011-09-28 with 6 public-safe observations.

483· Form 483 issued6 observations

Tony's Smoke House & Cannery, Inc. · Oregon City, United States · Issued September 28, 2011

Overview

  • 6 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.

28 Sep 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Devon M Shoop

28 Sep 2011
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Devon M Shoop

28 Sep 2011
21 CFR 123.6(d)

Signed and dated

Cited by Devon M Shoop

28 Sep 2011
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Devon M Shoop

28 Sep 2011
21 CFR 123.9(a)

Records - content

Cited by Devon M Shoop

Inspected site

TSTony's Smoke House & Cannery, Inc.Oregon City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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