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Quinfica Laboratory

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3024039377

Recorded by FDA as QUINFICA LABORATORY

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Example subjectQuinfica Laborator added to Import Alert 16-129 (red list)

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As of October 26, 2026, Quinfica Laboratory is not on any FDA import alert in SupplierRadar's records; FDA refused 6 of its shipment lines between September 5, 2025 and December 2, 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
Vitamin b12 (cyanocobalamin) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Quinfica Laboratory

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

2025

  1. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry 799-8601591-7
    Source
  2. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry 799-3630660-6
    Source
  3. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry 799-3988225-6
    Source
  4. Import refusal
    Refused, Foods with supplemental nutrients added, with or without artifical sweetnersNO ENGLISHUNAPPROVEDEntry 799-6873313-1
    Source
  5. Import refusal
    Refused, 2 lines in one entry: Vitamin b12 (cyanocobalamin); Sodium ascorbate (vitamin)UNAPPROVEDEntry 799-1312419-6Show 2 lines
    Source

Refusal charges, in plain English

  • UNAPPROVED6 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 Quinfica Laboratory

Is Quinfica Laboratory on an FDA import alert?
No listing for Quinfica Laboratory appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
Has FDA refused shipments from Quinfica Laboratory?
Yes. FDA refused 6 shipment lines from Quinfica Laboratory between September 5, 2025 and December 2, 2025. The most recent, on December 2, 2025, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Quinfica Laboratory's shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 6 lines) and NO ENGLISH (required label information not in english, 1 line).
What is Quinfica Laboratory's FEI number?
Quinfica Laboratory's FDA Establishment Identifier (FEI) is 3024039377.

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Example subjectQuinfica Laborator 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.