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Form 483

Gland Chemicals Private Limited Form 483, 2012-10-10

FDA issued a Form 483 to Gland Chemicals Private Limited on 2012-10-10 with 5 public-safe observations.

483· Form 483 issued5 observations

Gland Chemicals Private Limited · Chennai, India · Issued October 10, 2012

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

10 Oct 2012
21 CFR 211.28(b)

Habits of good sanitation & health

Cited by Peter E Baker

10 Oct 2012
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Peter E Baker

10 Oct 2012
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Peter E Baker

10 Oct 2012
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Peter E Baker

10 Oct 2012
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Peter E Baker

Inspected site

GCGland Chemicals Private LimitedChennai, India

Inspection team

PEPeter E Baker

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF and 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