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 3015826782.
Observations10
Issue DateAugust 18, 2026
Status1 Related Warning Letter
Establishment TypeProducer of Sterile and Non Sterile Drug Products
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