Atlas

Form 483

Five Star Marine Exports Pvt. Limited Form 483, 2014-02-01

FDA issued a Form 483 to Five Star Marine Exports Pvt. Limited on 2014-02-01 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Five Star Marine Exports Pvt. Limited · Nellore, India · Issued February 1, 2014

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.

1 Feb 2014
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Mark E Farrell

1 Feb 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Mark E Farrell

1 Feb 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Mark E Farrell

1 Feb 2014
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Mark E Farrell

1 Feb 2014
21 CFR 123.9(a)

Records - content

Cited by Mark E Farrell

Inspected site

FSFive Star Marine Exports Pvt. LimitedNellore, India

Inspection team

MEMark E Farrell

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)(1)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)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)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