Form 483

Ocean Seafood Co Form 483, 2015-07-01

FDA issued a Form 483 to Ocean Seafood Co on 2015-07-01 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ocean Seafood Co · Buffalo, United States · Issued July 1, 2015

Overview

  • 4 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.

1 Jul 2015
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Harry J Brewer

1 Jul 2015
21 CFR 110.93

Storage/transportation of finished goods (contamination)

Cited by Harry J Brewer

1 Jul 2015
21 CFR 123.12(a)(2)

Importer verification

Cited by Harry J Brewer

1 Jul 2015
21 CFR 123.9(a)

Records entries - timing

Cited by Harry J Brewer

Inspected site

OSOcean Seafood CoBuffalo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)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 4 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