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Form 483

Glenmark Pharmaceuticals Limited Form 483, 2019-09-27

FDA issued a Form 483 to Glenmark Pharmaceuticals Limited on 2019-09-27 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Glenmark Pharmaceuticals Limited · Colvale, India · Issued September 27, 2019

Overview

  • 4 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.

27 Sep 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Michele L Glendenning

27 Sep 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Michele L Glendenning

27 Sep 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Michele L Glendenning

27 Sep 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Michele L Glendenning

Inspected site

GPGlenmark Pharmaceuticals LimitedColvale, India

Inspection team

MLMichele L Glendenning

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited 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 4 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