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 3005580627.
Observations10
Issue DateSeptember 01, 2016
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Talk to a Specialist