# FDA 483 - Symrise, Inc - August 27, 2015

Source: https://www.keypedia.com/records/483/symrise-inc/600f6467-5fdf-4d85-b0f7-b39092da2701

> FDA 483 for Symrise, Inc on August 27, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symrise, Inc
- Inspection Date: 2015-08-27
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Symrise, an API manufacturer in Goose Creek, SC, was inspected by the FDA from August 26-27, 2015. The inspection revealed two significant issues: a failure to calibrate GC systems used for API testing and inadequate investigation and root cause analysis in deviation reports. These observations indicate deficiencies in quality control and deviation management.

## Related Documents

- [EIR - 2012-06-06](https://www.keypedia.com/records/eir/symrise-inc/8c307dab-7588-459e-85c9-747abb416dd7)
- [483 - 2025-02-28](https://www.keypedia.com/records/483/symrise-inc/84a265df-ee4b-4fa0-8127-f30957ada5c8)

## Related Officers

- [Shanna Pratt](https://www.keypedia.com/people/shanna-pratt/68e11983-f45b-47fa-84a8-2c0db7dfc949)

Company: https://www.keypedia.com/companies/symrise-inc/3c94427e-fd36-4498-bcbd-148093d778bd

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7