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 3001298034.
Observations9
Issue DateMay 05, 2016
Status1 Related Warning Letter
Establishment TypeProducer of Sterile Drug Products
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