FDA-Inspected Site

LNK International, Inc.

24 FDA inspections are on record for LNK International, Inc. in Hauppauge, United States.

483· Form 483 issued

Hauppauge, United States · Last updated July 9, 2026

Overview

  • 24 FDA inspections are on record.
  • 15 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-28.

At a glance

Inspections

24

Form 483s

15

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Oct 2025 – 28 Oct 2025Human Drugs483View 483 →
6 Dec 2022 – 13 Dec 2022Human Drugs483View 483 →
11 Jun 2021 – 1 Jul 2021Human Drugs483View 483 →
23 Jan 2019 – 8 Feb 2019Human DrugsWLView 483 →
28 Feb 2017 – 7 Mar 2017Human Drugs483View 483 →
19 Jan 2016 – 25 Jan 2016Human DrugsClean
20 Jan 2015 – 30 Jan 2015Human Drugs483View 483 →
6 Oct 2014 – 10 Oct 2014Human Drugs483On file
13 Jan 2014 – 17 Jan 2014Human Drugs483On file
19 Sep 2013 – 27 Sep 2013Human Drugs483On file
11 Jun 2013 – 14 Jun 2013Human Drugs483View 483 →
13 May 2013 – 24 May 2013Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

28 Oct 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Bijoy Panicker, Tanya R Syffrard, Amatul H Marium

28 Oct 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Bijoy Panicker, Tanya R Syffrard, Amatul H Marium

28 Oct 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Bijoy Panicker, Tanya R Syffrard, Amatul H Marium

13 Dec 2022
21 CFR 211.63

Equipment Design, Size and Location

Cited by Gam S Zamil, Terry Bridgewater

1 Jul 2021
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Bijoy Panicker, Brandy N Lepage, Tanya R Syffrard

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.198(a)Cited across public-safe Form 483 observations3x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x
21 CFR 211.67(a)Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.101(b)Cited across public-safe Form 483 observations1x
21 CFR 211.122(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LNK International, Inc.'s 15 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat