Form 483

New Wave Seafood Inc. Form 483, 2017-11-08

FDA issued a Form 483 to New Wave Seafood Inc. on 2017-11-08 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

New Wave Seafood Inc. · Stamford, United States · Issued November 8, 2017

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.

8 Nov 2017
21 CFR 117.4

Training of employees and records

Cited by Eduardo L Rodriguez

8 Nov 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Eduardo L Rodriguez

8 Nov 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Eduardo L Rodriguez

8 Nov 2017
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Eduardo L Rodriguez

8 Nov 2017
21 CFR 123.6(c)(7)

Records values/observations

Cited by Eduardo L Rodriguez

Inspected site

NWNew Wave Seafood Inc.Stamford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)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(c)(7)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