# FDA 483 - Zennova Pharmaceuticals (chengdu) Co.,ltd. - March 21, 2025

Source: https://www.keypedia.com/records/483/zennova-pharmaceuticals-chengdu-coltd/5deab8a8-36ee-4578-bf98-475151fff150

> FDA 483 for Zennova Pharmaceuticals (chengdu) Co.,ltd. on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zennova Pharmaceuticals (chengdu) Co.,ltd.
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zennova Pharmaceuticals (Chengdu) Co.,Ltd., a drug manufacturer, was cited for failing to establish adequate written procedures for production and process controls. This deficiency led to out-of-specification impurity levels in drug products following a packaging configuration change, with the root cause attributed to the container closure system. The firm did not adequately assess the impact of this change on product quality.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/zennova-pharmaceuticals-chengdu-coltd/e8258438-a66b-4826-bec4-475b6aef0eb6

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