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Diprofam Laboratories

FDA import alert and refusal historyVilla Nueva, GuatemalaFEI 3017708716

Recorded by FDA as DIPROFAM LABORATORIES

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Example subjectDiprofam Laboratorie added to Import Alert 16-129 (red list)

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As of October 25, 2026, Diprofam Laboratories is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines between June 12, 2025 and September 16, 2026, 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
Vitamin b12 (cyanocobalamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Diprofam Laboratories

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

2026

  1. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-9671096-5
    Source
  2. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-9432987-5
    Source
  3. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-9281476-1
    Source

2025

  1. Import refusal
    Refused, Laetrile (apricot pits), vit/min/protein/unconventional dietary spec for human/animal,n.e.c.NO ENGLISHUNAPPROVEDEntry AEK-8539732-9
    Source

Refusal charges, in plain English

  • UNAPPROVED4 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.

  • NO ENGLISH1 refused line

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

Questions about Diprofam Laboratories

Is Diprofam Laboratories on an FDA import alert?
No listing for Diprofam Laboratories 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 Diprofam Laboratories?
Yes. FDA refused 4 shipment lines from Diprofam Laboratories between June 12, 2025 and September 16, 2026. The most recent, on September 16, 2026, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Diprofam Laboratories's shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 4 lines) and NO ENGLISH (required label information not in english, 1 line).
What is Diprofam Laboratories's FEI number?
Diprofam Laboratories's FDA Establishment Identifier (FEI) is 3017708716.

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Example subjectDiprofam Laboratorie 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.