Form 483

Mr. Seafood Distributors Form 483, 2009-01-23

FDA issued a Form 483 to Mr. Seafood Distributors on 2009-01-23 with 6 public-safe observations.

483· Form 483 issued6 observations

Mr. Seafood Distributors · River Grove, United States · Issued January 23, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

23 Jan 2009
21 CFR 123.6(c)(2)

Critical control points

Cited by Pablo Alcantara, Brittany R Laymon, Jessica L Burley

23 Jan 2009
21 CFR 123.6(c)(3)

Critical limits

Cited by Pablo Alcantara, Brittany R Laymon, Jessica L Burley

23 Jan 2009
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Pablo Alcantara, Brittany R Laymon, Jessica L Burley

23 Jan 2009
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Pablo Alcantara, Brittany R Laymon, Jessica L Burley

23 Jan 2009
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Pablo Alcantara, Brittany R Laymon, Jessica L Burley

Inspected site

MSMr. Seafood DistributorsRiver Grove, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)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