LNK International, Inc.
Form 483 issued December 13, 2022 · Hauppauge, New York
- Inspection
- Dec 6 – Dec 13, 2022
- Investigators
- Gam S. Zamil· Terry Bridgewater
- Observations
- 1
- Pages
- 4
- FEI number
- 2432212
In short: On December 13, 2022, FDA issued a Form 483 with 1 observation to LNK International, Inc. in Hauppauge, New York (FEI 2432212) after an inspection that ran Dec 6 – Dec 13, 2022. The investigators were Gam S. Zamil and Terry Bridgewater. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LNK International, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected LNK International, Inc.?
Gam S. Zamil and Terry Bridgewater are named on this Form 483, for the inspection of Dec 6 – Dec 13, 2022. Each investigator has a profile showing what they cite most.
When was LNK International, Inc. inspected by FDA?
The inspection ran Dec 6 – Dec 13, 2022, and the Form 483 is dated December 13, 2022.
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.