Form 483

Boston Sword and Tuna, Inc. Form 483, 2016-06-29

FDA issued a Form 483 to Boston Sword and Tuna, Inc. on 2016-06-29 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Boston Sword and Tuna, Inc. · Boston, United States · Issued June 29, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

29 Jun 2016
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Thomas W Nerney

29 Jun 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Thomas W Nerney

29 Jun 2016
21 CFR 123.6(b)

No HACCP plan

Cited by Thomas W Nerney

29 Jun 2016
21 CFR 123.7(d)

Corrective action documentation

Cited by Thomas W Nerney

29 Jun 2016
21 CFR 123.9(a)

Records - content

Cited by Thomas W Nerney

Inspected site

BSBoston Sword and Tuna, Inc.Boston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.7(d)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 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