Form 483

Crown Fish Co Form 483, 2010-06-09

FDA issued a Form 483 to Crown Fish Co on 2010-06-09 with 6 public-safe observations.

483· Form 483 issued6 observations

Crown Fish Co · Bronx, United States · Issued June 9, 2010

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.

9 Jun 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Douglas G Ng

9 Jun 2010
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Douglas G Ng

9 Jun 2010
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Douglas G Ng

9 Jun 2010
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Douglas G Ng

9 Jun 2010
21 CFR 123.8(a)

Verification - reviewers qualifications

Cited by Douglas G Ng

Inspected site

CFCrown Fish CoBronx, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(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