Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002806457.
Observations8
Issue DateApril 25, 2023
StatusWarning Letter Issued
Related Inspections3
Establishment Details
Firm
Fenwal International, Inc.
Location
Bajos De Haina, -, Dominican Republic
FEI Number
3002806457
Product Type
Biologics
Issue Date
April 25, 2023
Country
Dominican Republic
Inspection History, 2016 to 2023
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.