Atlas

Form 483

USV Private Limited Form 483, 2015-03-27

FDA issued a Form 483 to USV Private Limited on 2015-03-27 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

USV Private Limited · Dabhel, Daman, India · Issued March 27, 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.

27 Mar 2015
21 CFR 211.111

Establishment of time limitations

Cited by Carla J Lundi

27 Mar 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Carla J Lundi

27 Mar 2015
21 CFR 211.111

Establishment of time limitations

Cited by Carla J Lundi

27 Mar 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Carla J Lundi

Inspected site

UPUSV Private LimitedDabhel, Daman, India

Inspection team

CJCarla J Lundi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.111Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited 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