Form 483

Gotham Seafood Corp Form 483, 2018-04-26

FDA issued a Form 483 to Gotham Seafood Corp on 2018-04-26 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Gotham Seafood Corp · Bronx, United States · Issued April 26, 2018

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

26 Apr 2018
21 CFR 123.12(a)(2)

Importer verification

Cited by Yuyan Liang

26 Apr 2018
21 CFR 123.6(b)

HACCP plan implementation

Cited by Yuyan Liang

26 Apr 2018
21 CFR 123.6(d)

Signed and dated

Cited by Yuyan Liang

26 Apr 2018
21 CFR 123.7(c)

Corrective action per regulation

Cited by Yuyan Liang

26 Apr 2018
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Yuyan Liang

Inspected site

GSGotham Seafood CorpBronx, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.7(c)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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