Fermenta Biotech Limited

2 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED1 refused line

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

Questions about Fermenta Biotech Limited

Is Fermenta Biotech Limited on an FDA import alert?

No listing for Fermenta Biotech Limited appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.

Has FDA refused shipments from Fermenta Biotech Limited?

Yes. FDA refused 1 shipment line from Fermenta Biotech Limited on October 7, 2025. The most recent, on October 7, 2025, was vitamin d2 (calciferol), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Fermenta Biotech Limited's shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).

When was Fermenta Biotech Limited last inspected by FDA?

FDA's most recent inspection of Fermenta Biotech Limited with a final classification is dated April 10, 2024 and was classified NAI (No Action Indicated).

What is Fermenta Biotech Limited's FEI number?

Fermenta Biotech Limited's FDA Establishment Identifier (FEI) is 3009928547.