LNK International, Inc.
Form 483 issued July 1, 2021 · Hauppauge, New York
- Inspection
- Jun 11 – Jul 1, 2021
- Investigators
- Bijoy Panicker· Brandy N. Lepage
- Observations
- 5
- Pages
- 6
- FEI number
- 2432212
In short: On July 1, 2021, FDA issued a Form 483 with 5 observations to LNK International, Inc. in Hauppauge, New York (FEI 2432212) after an inspection that ran Jun 11 – Jul 1, 2021. The investigators were Bijoy Panicker and Brandy N. Lepage. Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) 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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LNK International, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected LNK International, Inc.?
Bijoy Panicker and Brandy N. Lepage are named on this Form 483, for the inspection of Jun 11 – Jul 1, 2021. Each investigator has a profile showing what they cite most.
When was LNK International, Inc. inspected by FDA?
The inspection ran Jun 11 – Jul 1, 2021, and the Form 483 is dated July 1, 2021.
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.