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Form 483

LNK International, Inc. Form 483, 2013-06-14

FDA issued a Form 483 to LNK International, Inc. on 2013-06-14 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

LNK International, Inc. · Hauppauge, United States · Issued June 14, 2013

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.

14 Jun 2013
21 CFR 314.80(c)(2)(ii)(A)

Incomplete periodic safety report

Cited by Alice S Tsao

Inspected site

LILNK International, Inc.Hauppauge, United States

Inspection team

ASAlice S Tsao

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(c)(2)(ii)(A)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

Get the verbatim text of all 1 observation

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