Laboratorios Alfa, SRL

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

Refusal charges, in plain English

• UNAPPROVED2 refused lines

  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 Laboratorios Alfa, SRL

Is Laboratorios Alfa, SRL on an FDA import alert?

No listing for Laboratorios Alfa, SRL appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Dominican Republic page.

Has FDA refused shipments from Laboratorios Alfa, SRL?

Yes. FDA refused 2 shipment lines from Laboratorios Alfa, SRL between October 15, 2020 and November 22, 2021. The most recent, on November 22, 2021, was vitamin e (tocopherol), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Laboratorios Alfa, SRL's shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).

When was Laboratorios Alfa, SRL last inspected by FDA?

FDA's most recent inspection of Laboratorios Alfa, SRL with a final classification is dated September 16, 2022 and was classified VAI (Voluntary Action Indicated).

What is Laboratorios Alfa, SRL's FEI number?

Laboratorios Alfa, SRL's FDA Establishment Identifier (FEI) is 3003481013.