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Form 483

Granules Pharmaceuticals Inc. Form 483, 2020-01-17

FDA issued a Form 483 to Granules Pharmaceuticals Inc. on 2020-01-17 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Granules Pharmaceuticals Inc. · Chantilly, United States · Issued January 17, 2020

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.

17 Jan 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sena G Dissmeyer

17 Jan 2020
21 CFR 211.186(b)(9)

Complete instructions, procedures, specifications et. al.

Cited by Sena G Dissmeyer

17 Jan 2020
21 CFR 211.63

Equipment Design, Size and Location

Cited by Sena G Dissmeyer

Inspected site

GPGranules Pharmaceuticals Inc.Chantilly, United States

Inspection team

SGSena G Dissmeyer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 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