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 1000076625.
Observations11
Issue DateSeptember 08, 2021
Status3 Related Warning Letters
Establishment TypeProducer of Sterile Drug Products
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