# FDA 483 - Evonik Rexim (Nanning) Pharmaceutical Co. Ltd. - September 28, 2018

Source: https://www.globalkeysolutions.net/records/483/evonik-rexim-nanning-pharmaceutical-co-ltd/99fe7a38-3f93-434c-b05c-0dfa50adeef6

> FDA 483 for Evonik Rexim (Nanning) Pharmaceutical Co. Ltd. on September 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evonik Rexim (Nanning) Pharmaceutical Co. Ltd.
- Inspection Date: 2018-09-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Evonik Rexim Nanning Pharmaceutical Co., Ltd. was inspected by the FDA from September 25-28, 2018. The inspection revealed significant deficiencies related to the qualification and monitoring of cold temperature storage, including a lack of temperature mapping, inadequate review of temperature excursion data, and failure to communicate temperature alarms to the Quality department for deviation initiation. These issues indicate a lack of control over critical storage conditions for temperature-labile reagents.

## Related Officers

- [Steven P Donald](https://www.globalkeysolutions.net/people/steven-p-donald/431cb518-7687-408b-82e4-e525a135a26b)

Company: https://www.globalkeysolutions.net/companies/evonik-rexim-nanning-pharmaceutical-co-ltd/6324d0c3-0f41-474e-a714-d53659e1a622

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1