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 3012837733.
Observations4
Issue DateAugust 07, 2018
StatusNo Warning Letter
Establishment TypeProducer of Sterile and Non Sterile Drug Products
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