Drug establishmentActive, Registered FY2026FDA warning letter on file
Hikal Limited
Hikal Limited is an FDA-registered drug establishment (FEI 3009627283) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
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
Inspection history
FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.
Questions
Is Hikal Limited registered with the FDA?
Yes. Hikal Limited is an FDA-registered drug establishment (FEI 3009627283) in . Its current registration status is Active, Registered FY2026.
Has Hikal Limited received an FDA warning letter?
Yes. FDA issued a warning letter to Hikal Limited; the most recent is dated Aug 20, 2025 (CGMP/Active Pharmaceutical Ingredient (API)/Adulterated).
What does Hikal Limited do?
Hikal Limited's FDA-registered operations are: API MANUFACTURE.
Related facilities
Source: FDA public data · status as of 2026-06-01