Form 483

Pocas International Corp. Form 483, 2018-07-27

FDA issued a Form 483 to Pocas International Corp. on 2018-07-27 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Pocas International Corp. · S Hackensack, United States · Issued July 27, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

27 Jul 2018
21 CFR 1.504(d)

Review entity's hazard analysis

Cited by Vishal Patel

27 Jul 2018
21 CFR 1.506(a)(1)

Procedures - establish, approve supplier

Cited by Vishal Patel

27 Jul 2018
21 CFR 1.510(a)(1)

Record - keep

Cited by Vishal Patel

Inspected site

PIPocas International Corp.S Hackensack, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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