Kaylaan LLC
Form 483 issued March 1, 2024 · Floral Park, New York
- Inspection
- Feb 14 – Mar 1, 2024
- Investigator
- Vivin George
- Observations
- 13
- Pages
- 10
- FEI number
- 3021091668
In short: On March 1, 2024, FDA issued a Form 483 with 13 observations to Kaylaan LLC in Floral Park, New York (FEI 3021091668) after an inspection that ran Feb 14 – Mar 1, 2024. The investigator was Vivin George. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Vivin George
20 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmKaylaan LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kaylaan LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Kaylaan LLC?
Vivin George is named on this Form 483, for the inspection of Feb 14 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was Kaylaan LLC inspected by FDA?
The inspection ran Feb 14 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
How do I get the full Form 483 for Kaylaan LLC?
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.