LNK International, Inc.
Form 483 issued February 8, 2019 · Hauppauge, New York
- Inspection
- Jan 23 – Feb 8, 2019
- Investigator
- Guerlain Ulysse
- Observations
- 3
- Pages
- 6
- FEI number
- 2432212
In short: On February 8, 2019, FDA issued a Form 483 with 3 observations to LNK International, Inc. in Hauppauge, New York (FEI 2432212) after an inspection that ran Jan 23 – Feb 8, 2019. The investigator was Guerlain Ulysse. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigation of a drug complaint do not include the…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLNK International, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LNK International, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected LNK International, Inc.?
Guerlain Ulysse is named on this Form 483, for the inspection of Jan 23 – Feb 8, 2019. Each investigator has a profile showing what they cite most.
When was LNK International, Inc. inspected by FDA?
The inspection ran Jan 23 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
How do I get the full Form 483 for LNK International, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.