Saptalis Pharmaceuticals, LLC
Form 483 issued March 6, 2026 · Hauppauge, New York
- Inspection
- Mar 2 – Mar 6, 2026
- Observations
- 1
- Pages
- 2
- FEI number
- 3012152381
In short: On March 6, 2026, FDA issued a Form 483 with 1 observation to Saptalis Pharmaceuticals, LLC in Hauppauge, New York (FEI 3012152381) after an inspection that ran Mar 2 – Mar 6, 2026. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Questions about this 483
What did FDA find at Saptalis Pharmaceuticals, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
When was Saptalis Pharmaceuticals, LLC inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for Saptalis Pharmaceuticals, LLC?
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