Atlas

Form 483

USL Pharma Inc. dba Upsher-Smith Laboratories, LLC Form 483, 2010-04-30

FDA issued a Form 483 to USL Pharma Inc. dba Upsher-Smith Laboratories, LLC on 2010-04-30 with 1 public-safe observation.

483· Form 483 issued1 observation

USL Pharma Inc. dba Upsher-Smith Laboratories, LLC · Denver, United States · Issued April 30, 2010

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.

30 Apr 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Matthew R Dionne

Inspected site

UPUSL Pharma Inc. dba Upsher-Smith Laboratories, LLCDenver, United States

Inspection team

MRMatthew R Dionne

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

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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