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Form 483

JC World Bell Wholesale Co., Inc. Form 483, 2020-09-09

FDA issued a Form 483 to JC World Bell Wholesale Co., Inc. on 2020-09-09 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

JC World Bell Wholesale Co., Inc. · Hackensack, United States · Issued September 9, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Sep 2020
21 CFR 211.188(b)(1)

Dates not included for each significant step

Cited by Yvesna C Blaise

9 Sep 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Yvesna C Blaise

Inspected site

JWJC World Bell Wholesale Co., Inc.Hackensack, United States

Inspection team

YCYvesna C Blaise

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.188(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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