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Form 483

Alk-abello, Inc. Form 483, 2023-10-17

FDA issued a Form 483 to Alk-abello, Inc. on 2023-10-17 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Alk-abello, Inc. · Port Washington, United States · Issued October 17, 2023

Overview

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

Inspectional observations

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

17 Oct 2023
21 CFR 211.192

Written record of investigation incomplete

Cited by Shafiq Ahadi, Helen B Ricalde, Christian Lynch

Inspected site

AIAlk-abello, Inc.Port Washington, United States

Inspection team

SAShafiq Ahadi
HBHelen B Ricalde
CLChristian Lynch

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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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