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Form 483

Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany Form 483, 2023-02-17

FDA issued a Form 483 to Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany on 2023-02-17 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Halo Pharmaceutical, Inc. d/b/a Cambrex Whippany · Whippany, United States · Issued February 17, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Feb 2023
21 CFR 211.63

Equipment Design, Size and Location

Cited by Maotang Zhou, Robin P Mathew

17 Feb 2023
21 CFR 211.63

Equipment Design, Size and Location

Cited by Maotang Zhou, Robin P Mathew

Inspected site

HPHalo Pharmaceutical, Inc. d/b/a Cambrex WhippanyWhippany, United States

Inspection team

MZMaotang Zhou
RPRobin P Mathew

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.63Cited across public-safe Form 483 observations2x

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