# FDA 483 - Saptalis Pharmaceuticals LLC - March 06, 2026

Source: https://www.keypedia.com/records/483/saptalis-pharmaceuticals-llc/763863dc-fc49-4810-ae53-9007cbe2eb64

> FDA 483 for Saptalis Pharmaceuticals LLC on March 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saptalis Pharmaceuticals LLC
- Inspection Date: 2026-03-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Saptalis Pharmaceuticals LLC in Hauppauge, NY, a manufacturer of drug products, revealed significant deficiencies in equipment design and maintenance. Specifically, the firm failed to establish appropriate controls for the cleaning and reuse of transfer hoses, including a lack of replacement intervals, leachable studies, and written procedures. These issues indicate a potential risk to product quality and compliance with manufacturing standards.

## Related Documents

- [483 - 2018-10-30](https://www.keypedia.com/records/483/saptalis-pharmaceuticals-llc/53daa630-3cc6-4628-9ebd-c16eef898f78)
- [483 - 2023-03-17](https://www.keypedia.com/records/483/saptalis-pharmaceuticals-llc/b3f0de28-46f4-4f38-9983-f3f5a79aa93f)

## Related Officers

- [Emmanuel T. Donyina](https://www.keypedia.com/people/emmanuel-t-donyina/a8f23469-487e-490d-bf02-41b2a60bb396)
- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)

Company: https://www.keypedia.com/companies/saptalis-pharmaceuticals-llc/7e9c8055-910b-46e4-9d5a-ee86169bc91d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961