Form 483

Florida Smoked Fish, LLC Form 483, 2018-07-06

FDA issued a Form 483 to Florida Smoked Fish, LLC on 2018-07-06 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Florida Smoked Fish, LLC · Miami, United States · Issued July 6, 2018

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

6 Jul 2018
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Lissette Paiz

6 Jul 2018
21 CFR 123.11(b)

Sanitation monitoring

Cited by Lissette Paiz

6 Jul 2018
21 CFR 123.6(c)(2)

Critical control points

Cited by Lissette Paiz

6 Jul 2018
21 CFR 123.6(c)(3)

Critical limits

Cited by Lissette Paiz

6 Jul 2018
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Lissette Paiz

Inspected site

FSFlorida Smoked Fish, LLCMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
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)(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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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