# FDA 483 - Jiangsu Tohope Pharmaceutical Co., Ltd. - August 31, 2018

Source: https://www.keypedia.com/records/483/jiangsu-tohope-pharmaceutical-co-ltd/90ffc530-c715-4cd2-883b-71f9c18fe1f1

> FDA 483 for Jiangsu Tohope Pharmaceutical Co., Ltd. on August 31, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Tohope Pharmaceutical Co., Ltd.
- Inspection Date: 2018-08-31
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of JIANGSU TOHOPE PHARMACEUTICAL CO., LTD. in CHANGCHUN CITY, JIANGSU, CHINA, identified a significant issue with quality control procedures. The firm failed to ensure proper calibration entries for a pH meter used in the testing of Alpha Lipoic Acid, indicating a lapse in instrument control and record-keeping. This suggests a moderate severity issue related to quality system deficiencies.

## Related Documents

- [483 - 2018-08-31](https://www.keypedia.com/records/483/jiangsu-tohope-pharmaceutical-co-ltd/7e97b520-01d3-42ac-ad13-71ba73183911)

## Related Officers

- [Jose E. Perez-Soto](https://www.keypedia.com/people/jose-e-perez-soto/d7d8e54c-48ba-4bb6-be7d-974782433968)

Company: https://www.keypedia.com/companies/jiangsu-tohope-pharmaceutical-co-ltd/4b7351c7-56a4-41bf-bdb5-b8210cb590fd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6