# FDA 483 - Salvona Technologies, LLC - October 18, 2024

Source: https://www.globalkeysolutions.net/records/483/salvona-technologies-llc/2ab9bb10-ad78-4397-94e2-feddfe9e102c

> FDA 483 for Salvona Technologies, LLC on October 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Salvona Technologies, LLC
- Inspection Date: 2024-10-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Salvona Technologies, LLC in Hamilton, NJ, was inspected by the FDA, revealing significant deficiencies across its manufacturing and quality control operations. The firm failed to establish adequate written procedures for process validation, equipment qualification, cleaning, stability testing, and quality control unit responsibilities. These issues indicate a broad failure to ensure the identity, strength, purity, and quality of their drug products.

## Related Officers

- [Suchan Kim](https://www.globalkeysolutions.net/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Sushan Rimal](https://www.globalkeysolutions.net/people/sushan-rimal/7ee0090a-b5eb-433b-a4ba-689b34567e94)
- [Jenny Sung](https://www.globalkeysolutions.net/people/jenny-sung/f0bfe57e-92b9-4879-9ac3-1e3483b6486a)

Company: https://www.globalkeysolutions.net/companies/salvona-technologies-llc/140213d6-45db-49bf-8609-d4c9b186a533

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248