Merck Centroamericana S.A.
FDA import alert and refusal historyunknown, GuatemalaFEI 3003810237
As of October 26, 2026, Merck Centroamericana S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines on May 25, 2018, 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 Merck Centroamericana S.A.
3 records, newest first. Each line links to the FDA page it came from.
2018
- Import refusalSource
Refused, 3 lines in one entry: Vitamin c (ascorbic acid); Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-4544605-8Show 3 linesHide lines
- Refused, Vitamin c (ascorbic acid)UNAPPROVEDEntry AEK-4544605-8Source
- Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-4544605-8Source
- Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry AEK-4544605-8Source
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 Merck Centroamericana S.A.
- Is Merck Centroamericana S.A. on an FDA import alert?
- No listing for Merck Centroamericana S.A. 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 Merck Centroamericana S.A.?
- Yes. FDA refused 3 shipment lines from Merck Centroamericana S.A. on May 25, 2018. The most recent, on May 25, 2018, was vitamin c (ascorbic acid), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Merck Centroamericana S.A.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 3 lines).
- What is Merck Centroamericana S.A.'s FEI number?
- Merck Centroamericana S.A.'s FDA Establishment Identifier (FEI) is 3003810237.
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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.