# FDA 483 - Jilin Asymchem Pharmaceuticals Co., Ltd. - April 30, 2026

Source: https://www.keypedia.com/records/483/jilin-asymchem-pharmaceuticals-co-ltd/5bd496db-dba6-4e5a-93f8-0d6d0cdd42c6

> FDA 483 for Jilin Asymchem Pharmaceuticals Co., Ltd. on April 30, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jilin Asymchem Pharmaceuticals Co., Ltd.
- Inspection Date: 2026-04-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Jilin Asymchem Pharmaceuticals Co., Ltd. in Dunhua, China, received an FDA Form 483 following an inspection. The observations primarily concern inadequate written procedures and adherence to cleaning and calibration protocols, as well as deficiencies in process validation activities for drug substance manufacturing. These issues indicate potential risks to product quality and consistency.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/jilin-asymchem-pharmaceuticals-co-ltd/c22545b3-34e3-4854-b952-8dbf2ec1b318

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