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Form 483

USL Pharma Inc. dba Upsher-Smith Laboratories, LLC Form 483, 2019-11-07

FDA issued a Form 483 to USL Pharma Inc. dba Upsher-Smith Laboratories, LLC on 2019-11-07 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

USL Pharma Inc. dba Upsher-Smith Laboratories, LLC · Denver, United States · Issued November 7, 2019

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.

7 Nov 2019
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Erika V Butler

7 Nov 2019
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Erika V Butler

7 Nov 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Erika V Butler

7 Nov 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Erika V Butler

Inspected site

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

Inspection team

EVErika V Butler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 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