Atlas

Form 483

Unichem Laboratories Limited Form 483, 2015-04-17

FDA issued a Form 483 to Unichem Laboratories Limited on 2015-04-17 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Unichem Laboratories Limited · Pilerne Bardez, India · Issued April 17, 2015

Overview

  • 4 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.

17 Apr 2015
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Scott T Ballard

17 Apr 2015
21 CFR 211.63

Equipment Design, Size and Location

Cited by Scott T Ballard

17 Apr 2015
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Scott T Ballard

17 Apr 2015
21 CFR 211.63

Equipment Design, Size and Location

Cited by Scott T Ballard

Inspected site

ULUnichem Laboratories LimitedPilerne Bardez, India

Inspection team

STScott T Ballard

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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