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Catalent Argentina S.A.I.C.

FDA import alert and refusal historyBuenos Aires, ArgentinaFEI 3004258511

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Example subjectCatalent Argentina S.A.I.C added to Import Alert 16-129 (red list)

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As of October 26, 2026, Catalent Argentina S.A.I.C. is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines on January 31, 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
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Catalent Argentina S.A.I.C.

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

2023

  1. Import refusal
    Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-3104757-5Show 2 lines
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-3104757-5Source
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-3104757-5Source
    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 Catalent Argentina S.A.I.C.

Is Catalent Argentina S.A.I.C. on an FDA import alert?
No listing for Catalent Argentina S.A.I.C. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Argentina page.
Has FDA refused shipments from Catalent Argentina S.A.I.C.?
Yes. FDA refused 2 shipment lines from Catalent Argentina S.A.I.C. on January 31, 2023. The most recent, on January 31, 2023, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Catalent Argentina S.A.I.C.'s shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Catalent Argentina S.A.I.C.'s FEI number?
Catalent Argentina S.A.I.C.'s FDA Establishment Identifier (FEI) is 3004258511.

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Example subjectCatalent Argentina S.A.I.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.