# FDA 483 - Biovectra Inc. - September 12, 2024

Source: https://www.keypedia.com/records/483/biovectra-inc/690ec542-5cf2-49c8-b4ab-8624d6eb0ab8

> FDA 483 for Biovectra Inc. on September 12, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biovectra Inc.
- Inspection Date: 2024-09-12
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of BIOVECTRA Inc. in Windsor, Nova Scotia, revealed numerous deficiencies in their drug substance manufacturing processes. Key issues included inadequate microbial control, insufficient deviation investigations, and poor adherence to and validation of standard operating procedures. The findings indicate a lack of robust quality systems and controls over critical aspects of drug substance production.

## Related Officers

- [Bo Chi, Ph.D., Microbiologist](https://www.keypedia.com/people/bo-chi-phd-microbiologist/69ddbe08-9e55-44fa-8cc3-96b19c9b21fd)
- [Esther C. Rhee, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/esther-c-rhee-phd-pharmaceutical-scientist/74a86d2f-5dca-4c1f-88d3-8d01e509d664)
- [Farzaneh Dellilbavi-Ragheb, Ph.D., Biologist](https://www.keypedia.com/people/farzaneh-dellilbavi-ragheb-phd-biologist/f531abcd-718d-478e-8def-b8452f6e6226)

Company: https://www.keypedia.com/companies/biovectra-inc/46cb104d-9e11-4208-8344-cc8186412a02

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4