FDA Inspections, Warning Letters and Import Refusals: Mexico
FDA has recorded 1,207 inspections of firms in Mexico, 52 of them (4.3%) classified OAI. It has issued 88 warning letters to firms there and refused 108,157 import shipments. 3,367 firms in Mexico are named on FDA import alerts.
OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.
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By year
The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.
Mexico: FDA inspections per year
2017: 78 inspections 78 2017 2018: 148 inspections 148 2018 2019: 73 inspections 73 2019 2020: 13 inspections 13 2020 2021: 23 inspections 23 2021 2022: 49 inspections 49 2022 2023: 73 inspections 73 2023 2024: 63 inspections 63 2024 2025: 92 inspections 92 2025 2026: 70 inspections 70 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 70 0 0.0% 2 1,901 2025 92 2 2.2% 0 2,445 2024 63 0 0.0% 4 1,959 2023 73 4 5.5% 3 2,099 2022 49 5 10.2% 8 3,029 2021 23 0 0.0% 33 1,582 2020 13 2 15.4% 16 1,605 2019 73 5 6.8% 2 1,444 2018 148 2 1.4% 2 1,686 2017 78 2 2.6% 1 1,928
Latest OAI inspections
Date Facility Product type
Dec 19, 2025 Laboratorios Jaloma S.A. De C.V. Drugs May 8, 2025 Sabores Mexicanos Gourmet, S.A. De C.V. Food/Cosmetics Nov 10, 2023 Betone, S.A. De C.V. Drugs May 12, 2023 Glicerinas Industriales, S.A De C.V Drugs Apr 22, 2023 AGRICOLA SKY RANCH, S. DE R.L. DE C.V. Food/Cosmetics Feb 2, 2023 Grupo De Hongo Zeta Endotzi SPR De RL Food/Cosmetics Oct 28, 2022 Broncolin, S.A. De C.V. Drugs Oct 14, 2022 Zermat Internacional, S.A. De C.V. Drugs Sep 29, 2022 MBB Production Mexico S. De R.L. De C.V. Drugs May 27, 2022 Degasa S.A. De C.V. Drugs Apr 19, 2022 Eksa Mills S.A. De C.V. Drugs Feb 28, 2020 Nartex Laboratorios Homeopaticos S.A. De C.V. Drugs Feb 7, 2020 Skin Ecoguard S.A. De C.V. Drugs Dec 20, 2019 Signa S.A. De C.V. Drugs Dec 13, 2019 Sicor De Mexico S.A. De C.V. Drugs Dec 6, 2019 BOEHRINGER INGELHEIM PROMECO S.A. De C.V. Drugs Sep 13, 2019 Tonic Life S De RL Food/Cosmetics Aug 16, 2019 Corporativo Serysi, S. De R.L. De C.V. Drugs Jul 13, 2018 Herbal Solutions Health, S.A. De C.V Food/Cosmetics Mar 23, 2018 Jabones Y Productos Especializados SA De CV Drugs Sep 8, 2017 Degasa S.A. De C.V. Drugs Mar 9, 2017 PROSANA DISTRIBUCIONES SA DE CV Drugs Aug 19, 2016 Apicola De Allende, S.A. De C.V. Food/Cosmetics Sep 17, 2015 Rancho Don Juanito S. De R.L. De C. V. Food/Cosmetics Jun 10, 2015 SeaLand FrutCo S.A. De C.V. Food/Cosmetics
Showing the latest 25 of 52.
Latest warning letters
Date Firm Product type FDA center
May 22, 2026 Laboratorios Jaloma S.A. De C.V. Drugs CDER Jan 7, 2026 Unomedical Device S.A. De C.V. Devices CDRH Aug 27, 2024 Naturistas Especializados Drugs CDER Aug 6, 2024 Citgo / Snack Shop Tobacco CTP Mar 21, 2024 Betone, S.A. De C.V. Drugs CDER Jan 16, 2024 Glicerinas Industriales, S.A De C.V Drugs CDER Aug 7, 2023 Laavo Clean, S.A. De C.V. Drugs CDER Apr 6, 2023 Zermat Internacional, S.A. De C.V. Drugs CDER Mar 14, 2023 Procter & Gamble Manufacturing Mexico, S. De R.L. De C.V. Drugs CDER Oct 5, 2022 Eksa Mills S.A. De C.V. Drugs CDER Jul 21, 2022 JOSE MIGUEL GUTIERREZ SALAS Drugs CDER Jun 27, 2022 DDI MULTINACIONAL SA DE CV Drugs CDER Jun 27, 2022 Noticias Mexico Hoy Grupo Multimedia, S.A. De C.V. Drugs CDER Jun 22, 2022 Industrias Cklass S De RL De CV Drugs CDER Jun 14, 2022 Glicerinas Industriales, S.A De C.V Drugs CDER May 23, 2022 Grimann, S.A. De C.V. Drugs CDER May 9, 2022 Marindustrias S.A. De C.V. Food/Cosmetics CFSAN Dec 15, 2021 Maquiladora Miniara SA De CV Drugs CDER Oct 7, 2021 Notarika, S.A. De C.V. Drugs CDER Sep 30, 2021 Limpo Quimicos, SA De CV Drugs CDER Sep 29, 2021 Healthy Foods & Nutrition Lab De Mexico S.A. De C.V. Drugs CDER Sep 15, 2021 Nanomateriales, SA De CV Drugs CDER Sep 15, 2021 Nanomateriales, SA De CV Drugs CDER Aug 10, 2021 Tropicosmeticos, S.A. De C.V. Drugs CDER Jun 3, 2021 DMM Vission, S.A. De C.V. Drugs CDER
Showing the latest 25 of 88.
Search every letter by company with the FDA warning letter search .
Latest import refusals
Date Firm Product category
Oct 22, 2026 Sanofi-Aventis De Mexico Drugs and Biologics Oct 22, 2026 ASPEN LABS SA DE CV Drugs and Biologics Oct 22, 2026 Gelpharma S.A. De C.V. Drugs and Biologics Oct 22, 2026 ORGANIC NAILS Cosmetics Oct 22, 2026 Mead Johnson & Company Human Foods Oct 22, 2026 Adrian Santiago Romero Human Foods Oct 21, 2026 NOVAG INFANCE SA DE CV Drugs and Biologics Oct 21, 2026 Laboratorios Alpharma S.A. De C.V. Drugs and Biologics Oct 21, 2026 PRODUCTOS MAVER S.A. D.E. C.V. Drugs and Biologics Oct 21, 2026 FARMACEUTICOS RAYERE SA DE CV Drugs and Biologics Oct 21, 2026 JR ISMERELY LABS Human Foods Oct 21, 2026 JR ISMERELY LABS Human Foods Oct 21, 2026 MARCAS NESTLE SA DE CV Human Foods Oct 20, 2026 Comercilizadora De Productos Agricolas Masejo, S De RL De CV Human Foods Oct 20, 2026 YAZMIN FRANCO RIVAS Human Foods Oct 20, 2026 YAZMIN FRANCO RIVAS Human Foods Oct 20, 2026 YAZMIN FRANCO RIVAS Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Comercializadora Pepsico Mexico, Human Foods Oct 20, 2026 Sabritas, S. De R.L. De C.V. Human Foods Oct 20, 2026 COMPANIA COMERCIAL HERDEZ, SA DE C.V Human Foods
Showing the latest 25 of 108,157.
See every import refusal from Mexico .
Firms on FDA import alerts
Published Firm Import alert List
Nov 10, 2026 ANAYELI MONTERROSAS ESTEBAN 99-05 red Nov 10, 2026 FGASGRO MEX S DE RL DE CV 99-05 red Nov 10, 2026 Instantia GS, S.A. De C.V. 99-19 red Nov 10, 2026 Rancho Barretos 99-05 red Nov 6, 2026 MIGUEL ANGEL TORRES LEON 99-05 red Nov 6, 2026 PRODUCTOS NAVARRO 99-05 red Nov 5, 2026 Cangrow International Farms, S.A.P.I. De C.V. 99-05 red Nov 5, 2026 ELIZABETH ANTONIO CHAVEZ 99-05 red Nov 5, 2026 RICARDO ANASTACIO HERNANDEZ 99-05 red Nov 5, 2026 SERGIO ALEJANDRO OLEA VAZQUEZ 99-05 red Nov 4, 2026 Frut Tega Sa De Cv 99-05 red Nov 4, 2026 FRUT TEGA SA DE CV 99-05 red Nov 4, 2026 HERASMO SANDOVAL JAUREZ 99-05 red Nov 4, 2026 Marcelino Trinidad,Roberto 99-05 red Nov 2, 2026 AGUSTIN VALLEJO BETAN 99-05 red Nov 2, 2026 JOSE JUAN PEREZ RUIZ 99-05 red Nov 2, 2026 YAZMIN FRANCO RIVAS 99-05 red Oct 29, 2026 LUCIA ROSAS MENDOZA 99-05 red Oct 27, 2026 DON PANCHO VEGETALES SPR DE RL 99-23 red Oct 16, 2026 LABORATORIO Y RED DE DISTRIBUCION 99-39 red Oct 16, 2026 Productos Carey S.A. De C.V. 45-02 red Oct 13, 2026 COMERCIALIZADORA SOFINIC SA DE CV 45-02 red Oct 13, 2026 OSCAR ANDRADE SILVA 99-05 red Oct 9, 2026 Daniel Arreola Garcia 99-05 red Oct 9, 2026 Sunset Mangos, S.A. De C.V. 99-23 red
Showing the latest 25 of 3,367.
Most-inspected facilities
Facility City Inspections OAI Latest
Sicor De Mexico S.A. De C.V. Lerma De Villada 7 1 Jun 16, 2026 BOEHRINGER INGELHEIM PROMECO S.A. De C.V. Xochimilco 7 1 Feb 9, 2024 Signa S.A. De C.V. Toluca De Lerdo 6 1 Apr 15, 2022 Laboratorios Jaloma S.A. De C.V. Guadalajara 5 2 Dec 19, 2025 Selder S.A. De C.V. Ciudad De Mexico 5 1 Dec 20, 2024 Fermic S.A. De C.V. Ciudad De Mexico 5 0 Dec 13, 2024 Fersinsa GB, SA De CV Ramos Arizpe 5 0 Sep 23, 2022 Productos Roche S.A. De C. V. Toluca De Lerdo 5 0 Mar 3, 2017 Bayer De Mexico, S.A De C.V Ixtaczoquitlan 4 0 Jun 5, 2026 MAYEJ COMERCIALIZADORA S. De R.L. De C.V. Pueblo Acatzingo De Hidalgo 4 0 Sep 22, 2025 Mead Johnson Nutricionales De Mexico, S. De R.L. De C.V. Delicias 4 0 Apr 4, 2025 Compania Internacional De Comercio, S.A.P.I. De C.V. Ciudad De Mexico 4 2 Dec 6, 2024 Distribuidora Comercial Jafra S.A. De C.V. Santa Rosa Jauregui 4 0 Nov 17, 2023 Rancho Don Juanito S. De R.L. De C. V. San Quintin 4 1 Apr 20, 2023 Grisi Hnos, S.A. De C.V. Ciudad De Mexico 4 0 Oct 21, 2022
See each facility's Form 483 observations with the FDA 483 search .