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FDA Import Refusal 1FX-3564313-8/20001/1 — Patheon Puerto Rico, Inc.

Patheon Puerto Rico, Inc. — FEI 3003113148

The FDA refused shipment 1FX-3564313-8/20001/1 from Patheon Puerto Rico, Inc. (United States) on May 20, 2026. The refused product falls under Drugs and Biologics — SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC). Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 20, 2026
Country
United States
Product Category
Drugs and Biologics
Product Code
61PCA68 SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
Charges
118,3280

Recent inspections

  • 1174359 (VAI Tue Jul 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106702 (VAI Tue Oct 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053901 (VAI Thu May 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976890 (VAI Tue Jun 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941475 (VAI Thu Sep 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-5554546-9/31/1 (Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4845091-8/11/1 (Mon Mar 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2943679-5/11/1 (Mon Feb 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0800091-1/31/1 (Fri Feb 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6461927-2/11/1 (Thu Apr 09 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources