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 3003434972.
Observations3
Issue DateOctober 24, 2018
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections8
Establishment Details
Firm
Wedgewood Connect, LLC
Issued To
Leiter's Enterprises, Inc. dba Leiter's
Location
San Jose, California, United States
FEI Number
3003434972
Establishment Type
Outsourcing Facility
Product Type
Outsourcing Facility
Issue Date
October 24, 2018
Country
United States
Inspection History, 2013 to 2025
VAI5
OAI3
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.