# FDA 483 - Symrise, S. de R.L de C.V. - May 23, 2025

Source: https://www.globalkeysolutions.net/records/483/symrise-s-de-rl-de-cv/2b8473ab-67b0-42ac-b22e-22aa3d9621fd

> FDA 483 for Symrise, S. de R.L de C.V. on May 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symrise, S. de R.L de C.V.
- Inspection Date: 2025-05-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Synrise, S. de R.L. de C.V. in San Nicolas de Los Garza, Mexico, was cited for multiple significant deficiencies in its manufacturing processes and quality control. The inspection revealed failures to investigate critical deviations, establish proper procedures for investigations, adequately test incoming materials, and ensure quality unit oversight of OOS reports and annual product reviews. Additionally, the firm lacked validated manufacturing processes, a documented stability testing program, and adherence to pre-approved batch records.

## Related Documents

- [483 - 2018-07-22](https://www.globalkeysolutions.net/records/483/symrise-s-de-rl-de-cv/3d11cfa6-4797-4401-b579-cc261fdae9b5)
- [483 - 2018-09-21](https://www.globalkeysolutions.net/records/483/symrise-s-de-rl-de-cv/7139edbd-5b83-462c-973b-62d468f1848d)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.globalkeysolutions.net/companies/symrise-s-de-rl-de-cv/d361030e-c885-43cc-8647-fb4b7807f26f

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8