FACEMA S.A. De C.V.
FDA import alert and refusal historySan Salvador, El SalvadorFEI 3004313809
As of October 26, 2026, FACEMA S.A. De C.V. (San Salvador, El Salvador) is on the red list of FDA Import Alert 99-42 (Foods: heavy metal (toxic element) contamination) for orgeat mix (horchata de morro), published by FDA on October 31, 2022, is also listed on Import Alert 45-02 (red list), and has 27 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 99-42 · red listIA 45-02 · red list
- Last import refusal
- Horchata (beverage base n.e.c.) · POISONOUS
- Last warning letter
- None found
- Last inspection
- Classified VAI (Voluntary Action Indicated)
Every FDA record for FACEMA S.A. De C.V.
30 records, newest first. Each line links to the FDA page it came from.
2024
2023
- Import refusalSource
Refused, 22 lines in one entry: Corn beverage base; Chewing gum (without chocolate) and 10 moreFSVP VIOEntry 176-1016394-5Show 22 linesHide lines
- Refused, Corn beverage baseFSVP VIOEntry 176-1016394-5Source
- Refused, Chewing gum (without chocolate)FSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Corn starchFSVP VIOEntry 176-1016394-5Source
- Refused, Chicken noodle soup, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Chicken noodle soup, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Chicken noodle soup, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Beef soup, plain, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Lollipop (without chocolate)FSVP VIOEntry 176-1016394-5Source
- Refused, Creamed, dried soup, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Beef noodle soup, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Corn starchFSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Flavored candy, soft (live savers, etc.), with fruit (without chocolate)FSVP VIOEntry 176-1016394-5Source
- Refused, Chicken soup, plain, driedFSVP VIOEntry 176-1016394-5Source
- Refused, Beverage base not mentioned elsewhere, n.e.c.FSVP VIOEntry 176-1016394-5Source
- Refused, Flavored candy, soft (live savers, etc.), with fruit (without chocolate)FSVP VIOEntry 176-1016394-5Source
- Refused, Taffy (toffee), kisses candy, hard, without nuts and fruit (without chocolate)FSVP VIOEntry 176-1016394-5Source
2022
- Import alert listingListed on Import Alert 99-42red listOrgeat Mix (Horchata De Morro)Source
- Import refusalRefused, Horchata (beverage base n.e.c.)POISONOUSEntry 176-1004390-7Source
2013
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and Econ; Foodborne Biological HazardsSource
2010
- Import alert listingListed on Import Alert 45-02red listMargarita CookiesSource
Refusal charges, in plain English
- FSVP VIO22 refused lines
Importer not in compliance with FSVP
The importer of record appeared not to be in compliance with the Foreign Supplier Verification Program requirements of section 805 of the FD&C Act. The charge concerns the importer's program, not a test result on the food.
- POISONOUS5 refused lines
Poisonous or deleterious substance
The product appeared to bear or contain a poisonous or deleterious substance which may render it injurious to health.
Questions about FACEMA S.A. De C.V.
- Is FACEMA S.A. De C.V. on an FDA import alert?
- Yes. As of October 26, 2026, FACEMA S.A. De C.V. is on the red list of FDA Import Alert 99-42, “Foods: heavy metal (toxic element) contamination”, for orgeat mix (horchata de morro); FDA published the listing on October 31, 2022.
- Has FDA refused shipments from FACEMA S.A. De C.V.?
- Yes. FDA refused 27 shipment lines from FACEMA S.A. De C.V. between October 21, 2022 and December 31, 2024. The most recent, on December 31, 2024, was horchata (beverage base n.e.c.), charged as POISONOUS (poisonous or deleterious substance).
- Why did FDA refuse FACEMA S.A. De C.V.'s shipments?
- The most frequent charges are FSVP VIO (importer not in compliance with fsvp, 22 lines) and POISONOUS (poisonous or deleterious substance, 5 lines).
- When was FACEMA S.A. De C.V. last inspected by FDA?
- FDA's most recent inspection of FACEMA S.A. De C.V. with a final classification is dated April 23, 2013 and was classified VAI (Voluntary Action Indicated).
- What is FACEMA S.A. De C.V.'s FEI number?
- FACEMA S.A. De C.V.'s FDA Establishment Identifier (FEI) is 3004313809.
- Can shipments from FACEMA S.A. De C.V. still enter the U.S.?
- Shipments of orgeat mix (horchata de morro) from FACEMA S.A. De C.V. can be detained without physical examination under Import Alert 99-42; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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