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 3005287250.
Observations7
Issue DateJuly 10, 2015
StatusNo Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections2
Establishment Details
Firm
Region Care, Inc.
Location
Great Neck, New York, United States
FEI Number
3005287250
Establishment Type
Outsourcing Facility
Product Type
Outsourcing Facility
Issue Date
July 10, 2015
Country
United States
Inspection History, 2014 to 2016
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.