Form 483

LNK International, Inc. Form 483, 2022-12-13

FDA issued a Form 483 to LNK International, Inc. on 2022-12-13 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

LNK International, Inc. · Hauppauge, United States · Issued December 13, 2022

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.

13 Dec 2022
21 CFR 211.63

Equipment Design, Size and Location

Cited by Gam S Zamil, Terry Bridgewater

Inspected site

LILNK International, Inc.Hauppauge, United States

Inspection team

TBTerry Bridgewater

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.63Cited across public-safe Form 483 observations1x

Source document

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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