Atlas

Form 483

Vince's Shellfish Co, Inc. Form 483, 2015-07-16

FDA issued a Form 483 to Vince's Shellfish Co, Inc. on 2015-07-16 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Vince's Shellfish Co, Inc. · San Bruno, United States · Issued July 16, 2015

Overview

  • 10 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.

16 Jul 2015
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Jeanne A Young

16 Jul 2015
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Jeanne A Young

16 Jul 2015
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Jeanne A Young

16 Jul 2015
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Jeanne A Young

16 Jul 2015
21 CFR 123.9(a)

Records - content

Cited by Jeanne A Young

Inspected site

VSVince's Shellfish Co, Inc.San Bruno, United States

Inspection team

JAJeanne A Young

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations2x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations2x
21 CFR 123.9(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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