# FDA 483 - Symrise, S. de R.L de C.V. - July 22, 2018

Source: https://www.keypedia.com/records/483/symrise-s-de-rl-de-cv/3d11cfa6-4797-4401-b579-cc261fdae9b5

> FDA 483 for Symrise, S. de R.L de C.V. on July 22, 2018. 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: 2018-07-22
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: During an FDA inspection from July 17-22, 2018, at Symrise, S. de R.L. de C.V., a manufacturer located in San Nicolas de los Garza, Nuevo Leon, Mexico, several observations were made.

**Observation 1: Lack of Quality Unit oversight and control of documents.**
*   There was insufficient control over the issuance of batch and production control records for drug product manufacturing.
*   Instrument identification numbers for API analysis were not documented in batch records or MYSAP analytical data.
*   QC analysts could delete raw chromatographic data files in Total Chrome software.

**Observation 2: Absence of written procedures for production and process controls.**
*   No written procedures existed for finished product labeling.
*   No written procedures for shipping crude (b)(4) to (b)(4) and QC release/return of finished API (b)(4).
*   No written procedures for QC release based on Certificate of Analysis for raw materials (b)(4) Powder and (b)(4) in (b)(4).
*   No written procedures for user rights and privileges of instrument software, such as Total Chrome.

**Observation 3: Failure to conduct process validation on drug manufacturing.**
*   The firm did not validate the number of times the (b)(4) process step could be repeated for the API (b)(4).
*   The number of times the

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## Related Officers

- [Kara Dobbin](https://www.keypedia.com/people/kara-dobbin/0b35e025-4389-46df-abcb-30e70693f62b)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe