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Form 483

Mylan Laboratories Limited Form 483, 2019-01-18

FDA issued a Form 483 to Mylan Laboratories Limited on 2019-01-18 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Mylan Laboratories Limited · Nasik, Nashik, India · Issued January 18, 2019

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

18 Jan 2019
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Kellia N Hicks

18 Jan 2019
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Kellia N Hicks

18 Jan 2019
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Kellia N Hicks

18 Jan 2019
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Kellia N Hicks

18 Jan 2019
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Kellia N Hicks

Inspected site

MLMylan Laboratories LimitedNasik, Nashik, India

Inspection team

KNKellia N Hicks

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 6 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