Form 483

Ocean Jewels, Ltd Form 483, 2016-02-17

FDA issued a Form 483 to Ocean Jewels, Ltd on 2016-02-17 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Ocean Jewels, Ltd · Los Angeles, United States · Issued February 17, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

17 Feb 2016
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sara J Dent Acosta

17 Feb 2016
21 CFR 123.6(c)(3)

Critical limits

Cited by Sara J Dent Acosta

17 Feb 2016
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Sara J Dent Acosta

17 Feb 2016
21 CFR 123.9(a)

Records - content

Cited by Sara J Dent Acosta

17 Feb 2016
21 CFR 123.11(b)

Sanitation monitoring

Cited by Sara J Dent Acosta

Inspected site

OJOcean Jewels, LtdLos Angeles, 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(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)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 5 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