Atlas

Form 483

Mylan Laboratories Limited Form 483, 2011-05-27

FDA issued a Form 483 to Mylan Laboratories Limited on 2011-05-27 with 3 public-safe observations.

483· Form 483 issued3 observations

Mylan Laboratories Limited · Nasik, Nashik, India · Issued May 27, 2011

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.

27 May 2011
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Atul Agrawal

27 May 2011
21 CFR 211.194(a)

Complete test data included in records

Cited by Atul Agrawal

27 May 2011
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Atul Agrawal

Inspected site

MLMylan Laboratories LimitedNasik, Nashik, India

Inspection team

AAAtul Agrawal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited 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