Drug establishmentActive, Registered FY2026FDA warning letter on file

Kaylaan LLC

Kaylaan LLC is an FDA-registered drug establishment (FEI 3021091668) located in , New York. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-03-01) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Aug 19, 2024

CGMP/Finished Pharmaceuticals/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3021091668

Address

329 Jericho Turnpike, , New York

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Mar 1, 2024 · Official Action Indicated (OAI)

Form 483 observations

Mar 1, 2024, 13 observations: Lack of quality control unit; Testing and release for distribution; Component identity verification

Questions

Is Kaylaan LLC registered with the FDA?

Yes. Kaylaan LLC is an FDA-registered drug establishment (FEI 3021091668) in , New York. Its current registration status is Active, Registered FY2026.

Has Kaylaan LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Kaylaan LLC; the most recent is dated Aug 19, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Kaylaan LLC do?

Kaylaan LLC's FDA-registered operations are: Manufacturing.

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Source: FDA public data · status as of 2026-06-06