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Flora Manufacturing and Distributing Ltd.

FDA import alert and refusal historyBurnaby, CanadaFEI 3004284019

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Example subjectFlora Manufacturing and Distributing Ltd added to Import Alert 16-129 (red list)

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As of October 25, 2026, Flora Manufacturing and Distributing Ltd. is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on February 3, 2022, 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
Hawthorn (herbal & botanicals, not teas) · UNAPPROVED
Last warning letter
None found
Last inspection
Classified NAI (No Action Indicated)

Every FDA record for Flora Manufacturing and Distributing Ltd.

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

2022

  1. Inspection
    Inspection classified NAI (No Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological Hazards
    Source
  2. Import refusal
    Refused, Hawthorn (herbal & botanicals, not teas)UNAPPROVEDEntry 300-7474918-6
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    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 Flora Manufacturing and Distributing Ltd.

Is Flora Manufacturing and Distributing Ltd. on an FDA import alert?
No listing for Flora Manufacturing and Distributing Ltd. appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Canada page.
Has FDA refused shipments from Flora Manufacturing and Distributing Ltd.?
Yes. FDA refused 1 shipment line from Flora Manufacturing and Distributing Ltd. on February 3, 2022. The most recent, on February 3, 2022, was hawthorn (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Flora Manufacturing and Distributing Ltd.'s shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
When was Flora Manufacturing and Distributing Ltd. last inspected by FDA?
FDA's most recent inspection of Flora Manufacturing and Distributing Ltd. with a final classification is dated December 15, 2022 and was classified NAI (No Action Indicated).
What is Flora Manufacturing and Distributing Ltd.'s FEI number?
Flora Manufacturing and Distributing Ltd.'s FDA Establishment Identifier (FEI) is 3004284019.

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Example subjectFlora Manufacturing and Distributing 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.