Fenwal International, Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- Rd 357, Km 0.8, Maricao, Puerto Rico (PR) 00606, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 2627511 · DUNS 091164590
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIBlood and Blood Products2026-02-05
- VAIBlood and Blood Products2024-09-18
- NAIVaccines and Allergenic Products2022-09-24
- OAIBlood and Blood Products2022-09-24
- OAIBlood and Blood Products2021-09-24
- OAIDrug Quality Assurance2021-09-24
- OAIBlood and Blood Products2019-09-26
- VAIDrug Quality Assurance2017-08-22
- VAIDrug Quality Assurance2015-03-25
- NAIDrug Quality Assurance2014-02-21
- OAIDrug Quality Assurance2013-04-25
- VAIDrug Quality Assurance2012-02-24
- VAIDrug Quality Assurance2010-03-23
- OAIDrug Quality Assurance2009-02-02
Drugs this plant is listed as making
10 distinct drugs across 28 products name this site in their FDA label.
- Anticoagulant Citrate Dextrose (ACD)Fenwal, Inc.
- Anticoagulant Citrate Phosphate Dextrose (CPD)Fenwal, Inc.
- anticoagulant citrate phosphate dextrose (cpd) and adsol preservationFenwal, Inc.
- anticoagulant citrate phosphate dextrose (cpd) and adsol preservation kitFenwal, Inc.
- Anticoagulant Citrate Phosphate Dextrose (CPD) SolutionFenwal, Inc.
- Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation SolutionFenwal, Inc.
- Anticoagulant Citrate Phosphate Dextrose AdenineFenwal, Inc.
- Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) SolutionFenwal, Inc.
- Platelet Additive 3Fenwal, Inc.
- Solucion aditiva para plaquetas 3Fenwal, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.