Atlas

Form 483

Zydus Lifesciences Limited Form 483, 2022-03-10

FDA issued a Form 483 to Zydus Lifesciences Limited on 2022-03-10 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Zydus Lifesciences Limited · Jarod, India · Issued March 10, 2022

Overview

  • 6 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.

10 Mar 2022
21 CFR 211.166(a)

Written program not followed

Cited by Saleem A Akhtar

10 Mar 2022
21 CFR 211.166(a)

Written program not followed

Cited by Saleem A Akhtar

10 Mar 2022
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Saleem A Akhtar

10 Mar 2022
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Saleem A Akhtar

10 Mar 2022
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Saleem A Akhtar

Inspected site

ZLZydus Lifesciences LimitedJarod, India

Inspection team

SASaleem A Akhtar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.58Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 6 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