# FDA 483 - Saptalis Pharmaceuticals LLC - October 30, 2018

Source: https://www.keypedia.com/records/483/saptalis-pharmaceuticals-llc/53daa630-3cc6-4628-9ebd-c16eef898f78

> FDA 483 for Saptalis Pharmaceuticals LLC on October 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saptalis Pharmaceuticals LLC
- Inspection Date: 2018-10-30
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Saptalis Pharmaceuticals, LLC, a pharmaceutical drug manufacturer in Hauppauge, NY, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures and validation studies for equipment cleaning, inadequate warehousing procedures with missing temperature mapping, and unestablished accuracy and reproducibility for a critical test method. These issues indicate a failure to ensure product quality and compliance with cGMP regulations.

## Related Documents

- [483 - 2023-03-17](https://www.keypedia.com/records/483/saptalis-pharmaceuticals-llc/b3f0de28-46f4-4f38-9983-f3f5a79aa93f)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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