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FDA Inspections, Recalls & Compliance Actions in PR

Latest FDA inspections, compliance actions, recalls, import refusals, and facilities in PR — from official FDA enforcement data.

Inspections

Recent inspection classifications.

1327554 — Envasadora De Azucar (NAI Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1325072 — Sweet Ann Cake, Inc. (VAI Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1323806 — Puertorican Salsa Company, LLC (NAI Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1323002 — Industria Lechera De Puerto Rico, Inc. (NAI Thu Jun 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1325776 — Pall Life Sciences Puerto Rico LLC (NAI Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1320518 — Natural Slim, Inc. (VAI Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1322356 — Empresas Gutierrez del Arroyo, Inc (NAI Tue Jun 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1321750 — Paradise Plaza, Inc. (VAI Thu Jun 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1320360 — Cultivos del Nuevo Milenio, Inc. (NAI Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
1319036 — Luis Garraton, LLC (NAI Fri May 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions at facilities.

Warning Letter — Total (Thu Jul 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Oriental Food & Arts (Tue Jul 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Texaco / Star Mart (Tue Jul 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Stop & Go (Tue Jul 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Sunoco (Tue Jul 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — H&R Food and Liquor Market (Tue Jul 21 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Sunoco (Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Mobil (Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Supermercados Agranel (Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Warning Letter — Green Vape (Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent recalls tied to firms in the state.

D-0667-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
D-0669-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
D-0665-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
D-0668-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
D-0670-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
D-0666-2026 — Gasco Industrial Corp. (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
H-0913-2026 — Refresqueria Estrella Inc. (Tue May 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
Z-1634-2026 — AMO Puerto Rico Manufacturing, Inc. (Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
H-0361-2026 — Rovira Biscuit Corporation (Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
H-0360-2026 — Rovira Biscuit Corporation (Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent import refusals linked to facilities.

WSW-0039736-8/10001/1 — Baxter Healthcare Corporation (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
WSW-0039736-8/10001/4 — Baxter Healthcare Corporation (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
WSW-0039736-8/10001/3 — Baxter Healthcare Corporation (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
WSW-0039736-8/10001/2 — Baxter Healthcare Corporation (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
1FX-3564313-8/20001/1 — Patheon Puerto Rico, Inc. (Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
1FX-1757844-3/10003/1 — KANNP NAITO LTDA (Tue May 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
799-0337504-9/10001/1 — Bristol-Myers Squibb Manufacturing Company Unlimited Company (Wed Dec 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
799-9691005-7/10003/1 — Amgen Manufacturing Limited LLC (Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
799-7648528-6/10001/1 — IPR Pharmaceuticals, Inc. (Mon Nov 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)
AEK-7732651-8/10002/1 — Viatris Pharmaceuticals LLC (Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — United States)

Facilities by FEI.