Form 483

New England Lobster Company Inc. Form 483, 2017-01-24

FDA issued a Form 483 to New England Lobster Company Inc. on 2017-01-24 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

New England Lobster Company Inc. · Burlingame, United States · Issued January 24, 2017

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.

24 Jan 2017
21 CFR 123.10

HACCP training or qualification

Cited by Nympha V Florendo

24 Jan 2017
21 CFR 123.11(b)

Sanitation monitoring

Cited by Nympha V Florendo

24 Jan 2017
21 CFR 123.11(c)

Sanitation Records

Cited by Nympha V Florendo

24 Jan 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Nympha V Florendo

24 Jan 2017
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Nympha V Florendo

Inspected site

NENew England Lobster Company Inc.Burlingame, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)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 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