Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004562873.
Observations3
Issue DateFebruary 21, 2018
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections3
Establishment Details
Firm
Valgene Incorporated dba Cape Drugs
Location
Annapolis, Maryland, United States
FEI Number
3004562873
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
February 21, 2018
Country
United States
Inspection History, 2015 to 2021
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist