Laboratorios Andromaco S.A.
FDA import alert and refusal historyPenalolen, ChileFEI 3008089871
As of October 26, 2026, Laboratorios Andromaco S.A. is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on February 2, 2017, 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 Laboratorios Andromaco S.A.
1 record, newest first. Each line links to the FDA page it came from.
2017
- Import refusalRefused, Vitamin c (ascorbic acid)UNAPPROVEDEntry 799-8951051-1Source
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 Laboratorios Andromaco S.A.
- Is Laboratorios Andromaco S.A. on an FDA import alert?
- No listing for Laboratorios Andromaco 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 Chile page.
- Has FDA refused shipments from Laboratorios Andromaco S.A.?
- Yes. FDA refused 1 shipment line from Laboratorios Andromaco S.A. on February 2, 2017. The most recent, on February 2, 2017, was vitamin c (ascorbic acid), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Laboratorios Andromaco S.A.'s shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
- What is Laboratorios Andromaco S.A.'s FEI number?
- Laboratorios Andromaco S.A.'s FDA Establishment Identifier (FEI) is 3008089871.
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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.