SupplierRadar

Prolab

FDA import alert and refusal historyGuatemala, GuatemalaFEI 3039586617

Recorded by FDA as PROLAB

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

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As of October 25, 2026, Prolab is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between October 22, 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 c (ascorbic acid) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Prolab

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

2025

  1. Import refusal
    Refused, Vitamin c (ascorbic acid)UNAPPROVEDEntry 799-8413405-8
    Source
  2. Import refusal
    Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 799-4187016-6
    Source

Refusal charges, in plain English

  • UNAPPROVED2 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 Prolab

Is Prolab on an FDA import alert?
No listing for Prolab 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 Prolab?
Yes. FDA refused 2 shipment lines from Prolab between October 22, 2025 and December 2, 2025. The most recent, on December 2, 2025, was vitamin c (ascorbic acid), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Prolab's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Prolab's FEI number?
Prolab's FDA Establishment Identifier (FEI) is 3039586617.

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Example subjectProla 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.