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Drodifarma Lab

FDA import alert and refusal historyGuatemala City, GuatemalaFEI 3034849601

Recorded by FDA as DRODIFARMA LAB

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Example subjectDrodifarma La added to Import Alert 16-129 (red list)

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As of October 25, 2026, Drodifarma Lab is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines on November 25, 2025, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Niacin (nicotinic acid) (vitamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Drodifarma Lab

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

2025

  1. Import refusal
    Refused, 2 lines in one entry: Niacin (nicotinic acid) (vitamin); Vitamin b1 (thiamine)UNAPPROVEDEntry 799-2991395-4Show 2 lines
    Source

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 Drodifarma Lab

Is Drodifarma Lab on an FDA import alert?
No listing for Drodifarma Lab appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
Has FDA refused shipments from Drodifarma Lab?
Yes. FDA refused 2 shipment lines from Drodifarma Lab on November 25, 2025. The most recent, on November 25, 2025, was niacin (nicotinic acid) (vitamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Drodifarma Lab's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Drodifarma Lab's FEI number?
Drodifarma Lab's FDA Establishment Identifier (FEI) is 3034849601.

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Example subjectDrodifarma La added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.