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Biokemical, S.A. de C.V

FDA import alert and refusal historySanto Tomas, El SalvadorFEI 3004697958

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Example subjectBiokemical, S.A. de C. added to Import Alert 16-129 (red list)

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As of October 26, 2026, Biokemical, S.A. de C.V is not on any FDA import alert in SupplierRadar's records; FDA refused 6 of its shipment lines between October 14, 2020 and April 26, 2023, 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
Glucosamine hydrochloride (herbal and botanicals, not teas ii) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Biokemical, S.A. de C.V

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

2023

  1. Import refusal
    Refused, Glucosamine hydrochloride (herbal and botanicals, not teas ii)UNAPPROVEDEntry AEK-3078930-7
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 8TQ-0147051-5Show 2 lines
    • Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 8TQ-0147051-5Source
    • Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 8TQ-0147051-5Source
    Source

2022

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry B4Y-0020817-5
    Source

2021

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.LABELINGNUTRIT LBLUNAPPROVEDEntry B4Y-0015644-0
    Source

2020

  1. Import refusal
    Refused, Vitamin, n.e.c.UNSAFE COLEntry B4Y-0015131-8
    Source

Refusal charges, in plain English

  • UNAPPROVED5 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.

  • LABELING1 refused line

    Fair Packaging and Labeling Act

    The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

  • NUTRIT LBL1 refused line

    Nutrition information missing from label

    The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

  • UNSAFE COL1 refused line

    Color additive unsafe under section 721

    The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

Questions about Biokemical, S.A. de C.V

Is Biokemical, S.A. de C.V on an FDA import alert?
No listing for Biokemical, S.A. de C.V appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the El Salvador page.
Has FDA refused shipments from Biokemical, S.A. de C.V?
Yes. FDA refused 6 shipment lines from Biokemical, S.A. de C.V between October 14, 2020 and April 26, 2023. The most recent, on April 26, 2023, was glucosamine hydrochloride (herbal and botanicals, not teas ii), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Biokemical, S.A. de C.V's shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and LABELING (fair packaging and labeling act, 1 line).
What is Biokemical, S.A. de C.V's FEI number?
Biokemical, S.A. de C.V's FDA Establishment Identifier (FEI) is 3004697958.

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Example subjectBiokemical, S.A. de C. 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.