Drug establishmentActive, Registered FY2026FDA warning letter on file

TYCHE INDUSTRIES LIMITED

TYCHE INDUSTRIES LIMITED is an FDA-registered drug establishment (FEI 3004790309) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-08-16) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 6, 2025

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Find this 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

3004790309

Address

6/223, ,

Establishment type

Drug establishment

Products / operations

Active pharmaceutical ingredient (API) manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Aug 16, 2024 · Official Action Indicated (OAI)
Jan 29, 2016 · No Action Indicated (NAI)

Form 483 observations

None on file

Questions

Is TYCHE INDUSTRIES LIMITED registered with the FDA?

Yes. TYCHE INDUSTRIES LIMITED is an FDA-registered drug establishment (FEI 3004790309) in . Its current registration status is Active, Registered FY2026.

Has TYCHE INDUSTRIES LIMITED received an FDA warning letter?

Yes. FDA issued a warning letter to TYCHE INDUSTRIES LIMITED; the most recent is dated Feb 6, 2025 (CGMP/Active Pharmaceutical Ingredient (API)/Adulterated).

What does TYCHE INDUSTRIES LIMITED do?

TYCHE INDUSTRIES LIMITED's FDA-registered operations are: Active pharmaceutical ingredient (API) manufacturing.

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