# FDA 483 - Qilu Antibiotics Pharmaceutical Co. , Ltd. - May 30, 2023

Source: https://www.keypedia.com/records/483/qilu-antibiotics-pharmaceutical-co-ltd/ea74fdfa-9617-4364-b095-fabb92116823

> FDA 483 for Qilu Antibiotics Pharmaceutical Co. , Ltd. on May 30, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Qilu Antibiotics Pharmaceutical Co. , Ltd.
- Inspection Date: 2023-05-30
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Qilu Antibiotics Pharmaceutical Co., LTD. in Licheng District, Shandong, was inspected and found to have significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed failures in aseptic processing simulations, environmental control systems, laboratory controls, and quality unit training procedures, indicating a high severity of non-compliance with sterile manufacturing regulations.

## Related Documents

- [483 - 2021-04-26](https://www.keypedia.com/records/483/qilu-antibiotics-pharmaceutical-co-ltd/2d6fdeb5-e3e2-479b-b716-137aae6b5847)

## Related Officers

- [Suzanne N. Vallez](https://www.keypedia.com/people/suzanne-n-vallez/7c16e0f4-c0b1-4f50-adfa-b1dc534694cd)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/qilu-antibiotics-pharmaceutical-co-ltd/f1c696c7-317f-4fb9-92a1-df8381af004c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c