# FDA 483 - Qilu Antibiotics Pharmaceutical Co. , Ltd. - April 26, 2021

Source: https://www.keypedia.com/records/483/qilu-antibiotics-pharmaceutical-co-ltd/2d6fdeb5-e3e2-479b-b716-137aae6b5847

> FDA 483 for Qilu Antibiotics Pharmaceutical Co. , Ltd. on April 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu Antibiotics Pharmaceutical Co. , Ltd.
- Inspection Date: 2021-04-26
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD identified significant deficiencies in aseptic processing, including inadequate fumigation validation and unapproved cleaning procedures for Grade A areas. The firm also failed to follow procedures for preventing microbiological contamination, as evidenced by defective sterile drug product vials not being rejected during visual inspection. Additionally, equipment cleaning and use logs lacked proper two-person verification, indicating a breakdown in documentation practices.

## Related Documents

- [483 - 2023-05-30](https://www.keypedia.com/records/483/qilu-antibiotics-pharmaceutical-co-ltd/ea74fdfa-9617-4364-b095-fabb92116823)

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3