# FDA 483 - BBC Group Limited - March 22, 2021

Source: https://www.keypedia.com/records/483/bbc-group-limited/10960986-cc80-4d56-bd03-794f57aefb4c

> FDA 483 for BBC Group Limited on March 22, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BBC Group Limited
- Inspection Date: 2021-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: BBC Group Limited, a drug manufacturer in Zhangzhou, China, was cited for significant deficiencies in data integrity, quality control, and manufacturing practices during an FDA inspection. Observations included missing electronic data backups, inadequate computerized system controls, unvalidated analytical methods, and failures in stability testing, batch recordkeeping, equipment logs, equipment maintenance, and annual product reviews. These issues indicate a systemic lack of control over critical aspects of drug product manufacturing and quality assurance.

## 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/bbc-group-limited/81994ee7-8982-41a4-ad53-400a45077b4f

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1