Company
United StatesSaptalis Pharmaceuticals LLC, Hauppauge, NY – FDA Inspections
Inspection records and compliance data for Saptalis Pharmaceuticals LLC in Hauppauge, New York. 5 FDA inspections on record, 4 Form 483s, last inspected March 06, 2026.
Company Profile
This profile covers Saptalis Pharmaceuticals LLC based in Hauppauge, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 0
First inspected March 28, 2018. Last inspected March 6, 2026.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Computer control of master formula records1 inspection
- Equipment Design, Size and Location1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1305912 |
| September 9, 2025 | NAI | Human Drugs · Bioresearch Monitoring | 1283250 |
| March 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1200278 |
| October 30, 2018 | Not classified | Human Drugs | 1072233 |
| March 28, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1046656 |
FDA documents
People (5)
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Company Information
Name
Saptalis Pharmaceuticals LLC
FEI Number
3012152381
Address
20 Davids Dr, Hauppauge, New York 11788, United States
Country
United States
ID: 7e9c8055-910b-46e4-9d5a-ee86169bc91d