Atlas

Form 483

Zydus Lifesciences Limited Form 483, 2019-03-26

FDA issued a Form 483 to Zydus Lifesciences Limited on 2019-03-26 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Zydus Lifesciences Limited · Matoda, India · Issued March 26, 2019

Overview

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

Inspectional observations

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

26 Mar 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Matthew B Casale

26 Mar 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Matthew B Casale

Inspected site

ZLZydus Lifesciences LimitedMatoda, India

Inspection team

MBMatthew B Casale

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 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