# FDA 483 - Saptalis Pharmaceuticals LLC - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/saptalis-pharmaceuticals-llc/b3f0de28-46f4-4f38-9983-f3f5a79aa93f

> FDA 483 for Saptalis Pharmaceuticals LLC on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saptalis Pharmaceuticals LLC
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Saptalis Pharmaceuticals LLC in Hauppauge, NY, received a Form 483 with four observations during an inspection from March 9-17, 2023. The firm was cited for significant deficiencies including inadequate computer system controls allowing data deletion, insufficient written procedures for component testing, deficient in-process material testing and bulk hold time studies, and improper quarantine of rejected drug product containers. These findings highlight critical issues in data integrity, quality control, and material management practices.

## Related Documents

- [483 - 2018-10-30](https://www.globalkeysolutions.net/records/483/saptalis-pharmaceuticals-llc/53daa630-3cc6-4628-9ebd-c16eef898f78)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Amal H Mariun](https://www.globalkeysolutions.net/people/amal-h-mariun/619db06d-b5de-4f59-940e-563321695be9)

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

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