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HKM Farmacia de Manipulacao Ltda

FDA import alert and refusal historyPalhoca, BrazilFEI 3027591224

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Example subjectHKM Farmacia de Manipulacao Ltd added to Import Alert 16-129 (red list)

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As of October 26, 2026, HKM Farmacia de Manipulacao Ltda is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines on July 24, 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
Cat's claw (unad'gato), (herbal & botanicals, not teas) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for HKM Farmacia de Manipulacao Ltda

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

2025

  1. Import refusal
    Refused, 3 lines in one entry: Cat's claw (unad'gato), (herbal & botanicals, not teas); Coenzyme q10 (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) and 1 moreUNAPPROVEDEntry AEK-7360116-1Show 3 lines
    • Refused, Cat's claw (unad'gato), (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-7360116-1Source
    • Refused, Coenzyme q10 (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)UNAPPROVEDEntry AEK-7360116-1Source
    • Refused, Folic acid (vitamin)UNAPPROVEDEntry AEK-7360116-1Source
    Source

Refusal charges, in plain English

  • UNAPPROVED3 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 HKM Farmacia de Manipulacao Ltda

Is HKM Farmacia de Manipulacao Ltda on an FDA import alert?
No listing for HKM Farmacia de Manipulacao Ltda appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Brazil page.
Has FDA refused shipments from HKM Farmacia de Manipulacao Ltda?
Yes. FDA refused 3 shipment lines from HKM Farmacia de Manipulacao Ltda on July 24, 2025. The most recent, on July 24, 2025, was cat's claw (unad'gato), (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse HKM Farmacia de Manipulacao Ltda's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 3 lines).
What is HKM Farmacia de Manipulacao Ltda's FEI number?
HKM Farmacia de Manipulacao Ltda's FDA Establishment Identifier (FEI) is 3027591224.

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Example subjectHKM Farmacia de Manipulacao Ltd 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.