Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2627511.
Observations3
Issue DateMarch 23, 2010
Status1 Related Warning Letter
Related Inspections10
Establishment Details
Firm
Fenwal International, Inc.
Location
Maricao, Puerto Rico, United States
FEI Number
2627511
Product Type
Devices
Issue Date
March 23, 2010
Country
United States
Inspection History, 2012 to 2026
NAI3
VAI3
OAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.