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Form 483

Actavis Laboratories UT, Inc. Form 483, 2021-08-20

FDA issued a Form 483 to Actavis Laboratories UT, Inc. on 2021-08-20 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Actavis Laboratories UT, Inc. · Salt Lake City, United States · Issued August 20, 2021

Overview

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

Inspectional observations

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

20 Aug 2021
21 CFR 211.122(d)

Labels and labeling stored separately

Cited by Alan P Kurtzberg, Dustin M James

Inspected site

ALActavis Laboratories UT, Inc.Salt Lake City, United States

Inspection team

APAlan P Kurtzberg
DMDustin M James

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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  • 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