Supplier Records

Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

Tlajomulco De Zuniga, Mexico · Soft Drinks and Waters · FEI 3007502289 (the establishment identifier FDA assigns to one facility)

Public FDA records for this facility show 126 refusal episodes covering 441 refused shipment lines between 2019-01-01 and 2026-08-16, and 3 current import alert listing(s). A refusal episode groups refused lines that share the same FDA charges within a 30 day window, so one underlying event is counted once even when it refuses many shipments.

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Import alert listings

An import alert is FDA guidance that lets field staff detain products from listed firms at the border without physical examination (FDA calls this DWPE). Each entry below appears on the Red List of the linked alert, the list of firms subject to that detention, and matched this facility by name and full address. Alert pages can also carry a Green List naming firms FDA excluded from a countrywide alert's detention; Green List entries are not shown on this page.

AlertSubjectFirm listed
Import Alert 99-39Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded07/06/2022
Import Alert 45-02Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.03/30/2023
Import Alert 66-41Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.07/06/2022

Refusal history

Refused shipment lines by year, from FDA's import refusals dataset. This facility's underlying records are on the FDA Data Dashboard. Public data does not include how many shipments a firm made in total, so these are counts of refusals, and comparisons of refusal shares between firms are not possible from this source.

YearRefused lines
202010
20212
2022129
2023187
202451
202553
20269

Recent episodes

StartLinesProducts FDA charge codes
2026-08-032Human Drugs118, 75
2026-07-025Human Drugs75
2026-02-202Human Drugs118, 75
2025-12-121Human Drugs118, 3280
2025-11-261Human Drugs75
2025-11-141Soft Drinks and Waters260, 324, 482
2025-11-101Human Drugs75
2025-10-242Soft Drinks and Waters336, 75
2025-10-222Human Drugs75
2025-10-021Dietary Conventional Foods and Meal Replacements256, 260, 482, 75
2025-09-021Dietary Conventional Foods and Meal Replacements324, 75
2025-08-011Dietary Conventional Foods and Meal Replacements324, 75

Peer context

FDA records show at least one refusal since 2019 for 46 suppliers from Mexico in the same FDA industry code. The median for that group is 2 episodes in the same window. 98% of the group recorded fewer episodes than this facility.

About this record

Past events do not predict future outcomes. This page reports public FDA records as published on 2026-08-16. Import alert listings link to the FDA alert page they appear on; refusal and enforcement figures come from the FDA Data Dashboard datasets, reachable through the facility link above. FDA does not publish stable per-record links for individual refusals. This page does not evaluate whether any firm or shipment meets legal requirements, and FDA data can contain errors or later corrections. How these records are assembled · All suppliers