# FDA 483 - Qilu SYNVA Pharmaceutical Co. Ltd - May 16, 2025

Source: https://www.keypedia.com/records/483/qilu-synva-pharmaceutical-co-ltd/d5429ebd-a562-4752-85f4-d714c898528d

> FDA 483 for Qilu SYNVA Pharmaceutical Co. Ltd on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Qilu SYNVA Pharmaceutical Co. Ltd
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Qilu SYNVA Pharmaceutical Co., Ltd. in Dezhou, China, received a Form FDA 483 with five observations related to significant deficiencies in quality control, laboratory practices, and facility management. Issues included inadequate approval processes for product release, poor aseptic techniques during sterility testing, insufficient laboratory controls for smoke studies, non-representative raw material sampling, and improper identification of manufacturing equipment. These findings indicate a lack of robust quality systems and controls for API manufacturing.

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.keypedia.com/companies/qilu-synva-pharmaceutical-co-ltd/fda44d3b-5f42-4cde-9760-cf4147fc0ef8

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