Form 483

Maine Seafood Ventures LLC Form 483, 2015-01-30

FDA issued a Form 483 to Maine Seafood Ventures LLC on 2015-01-30 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Maine Seafood Ventures LLC · Saco, United States · Issued January 30, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

30 Jan 2015
21 CFR 123.6(c)(3)

Critical limits

Cited by Slater K Bartlett

30 Jan 2015
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Slater K Bartlett

30 Jan 2015
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Slater K Bartlett

30 Jan 2015
21 CFR 123.6(d)

Signed and dated

Cited by Slater K Bartlett

30 Jan 2015
21 CFR 123.9(a)

Records - content

Cited by Slater K Bartlett

Inspected site

MSMaine Seafood Ventures LLCSaco, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(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)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(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 6 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