Atlas

Form 483

Hikma Pharmaceuticals USA INC. Form 483, 2011-01-20

FDA issued a Form 483 to Hikma Pharmaceuticals USA INC. on 2011-01-20 with 1 public-safe observation.

483· Form 483 issued1 observation

Hikma Pharmaceuticals USA INC. · Columbus, United States · Issued January 20, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Jan 2011
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Nicholas L Paulin

Inspected site

HPHikma Pharmaceuticals USA INC.Columbus, United States

Inspection team

NLNicholas L Paulin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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