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 3012152381.
Observations1
Issue DateMarch 06, 2026
StatusNo Warning Letter
Establishment TypeDrug Product Manufacturer
Related Inspections4
Establishment Details
Firm
Saptalis Pharmaceuticals LLC
Location
Hauppauge, New York
FEI Number
3012152381
Establishment Type
Drug Product Manufacturer
Product Type
Drugs
Issue Date
March 06, 2026
Country
United States
Inspection History, 2018 to 2026
NAI1
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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