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 1000305672.
Observations16
Issue DateJuly 23, 2015
StatusNo Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections7
Establishment Details
Firm
Resilience US, Inc.
Issued To
Genzyme Corporation
Location
Allston, Massachusetts, United States
FEI Number
1000305672
Establishment Type
Drug Manufacturer
Product Type
Drugs
Issue Date
July 23, 2015
Country
United States
Inspection History, 2008 to 2019
NAI2
VAI2
OAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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