Gamma SA Laboratory
FDA import alert and refusal historyMixco, GuatemalaFEI 3023498718
Recorded by FDA as GAMMA SA LABORATORY
As of October 26, 2026, Gamma SA Laboratory is not on any FDA import alert in SupplierRadar's records; FDA refused 5 of its shipment lines between February 12, 2026 and February 20, 2026, 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, n.e.c. · NOT LISTED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Gamma SA Laboratory
5 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, n.e.c.; Folic acid (vitamin)NOT LISTEDUNAPPROVEDEntry AEK-9433073-3Show 2 linesHide lines
- Refused, Vitamin, n.e.c.NOT LISTEDUNAPPROVEDEntry AEK-9433073-3Source
- Refused, Folic acid (vitamin)NOT LISTEDUNAPPROVEDEntry AEK-9433073-3Source
- Import refusalSource
Refused, 3 lines in one entry: Glucosamine sulfate (herbal and botanicals, not teas ii); Folic acid (vitamin) and 1 moreUNAPPROVEDEntry AEK-9433064-2Show 3 linesHide lines
- Refused, Glucosamine sulfate (herbal and botanicals, not teas ii)UNAPPROVEDEntry AEK-9433064-2Source
- Refused, Folic acid (vitamin)UNAPPROVEDEntry AEK-9433064-2Source
- Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-9433064-2Source
Refusal charges, in plain English
- UNAPPROVED5 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.
- NOT LISTED2 refused lines
Product not listed with FDA
The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.
Questions about Gamma SA Laboratory
- Is Gamma SA Laboratory on an FDA import alert?
- No listing for Gamma SA 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 Gamma SA Laboratory?
- Yes. FDA refused 5 shipment lines from Gamma SA Laboratory between February 12, 2026 and February 20, 2026. The most recent, on February 20, 2026, was vitamin, n.e.c., charged as NOT LISTED (product not listed with fda).
- Why did FDA refuse Gamma SA Laboratory's shipments?
- The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and NOT LISTED (product not listed with fda, 2 lines).
- What is Gamma SA Laboratory's FEI number?
- Gamma SA Laboratory's FDA Establishment Identifier (FEI) is 3023498718.
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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.