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 3013452490.
Observations3
Issue DateJuly 26, 2017
Status1 Related Warning Letter
Establishment TypeProducer of Sterile Drug Products
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