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 3012038236.
Observations5
Issue DateAugust 09, 2019
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections3
Establishment Details
Firm
Stonegate Pharmacy LP
Location
Austin, Texas, United States
FEI Number
3012038236
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
August 09, 2019
Country
United States
Inspection History, 2016 to 2019
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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