Atlas

Form 483

Zydus Lifesciences Limited Form 483, 2012-10-04

FDA issued a Form 483 to Zydus Lifesciences Limited on 2012-10-04 with 3 public-safe observations.

483· Form 483 issued3 observations

Zydus Lifesciences Limited · Matoda, India · Issued October 4, 2012

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.

4 Oct 2012
21 CFR 211.63

Equipment Design, Size and Location

Cited by Edmund F Mrak

4 Oct 2012
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Edmund F Mrak

4 Oct 2012
21 CFR 211.165(c)

Sampling and testing plans not described

Cited by Edmund F Mrak

Inspected site

ZLZydus Lifesciences LimitedMatoda, India

Inspection team

EFEdmund F Mrak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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