# FDA 483 - Biovectra, Inc. - February 17, 2017

Source: https://www.keypedia.com/records/483/biovectra-inc/3bf401c7-eb39-461b-8c0f-cdd5e373fe9b

> FDA 483 for Biovectra, Inc. on February 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovectra, Inc.
- Inspection Date: 2017-02-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BioVectra Inc. in Charlottetown, PE, Canada, identified a significant issue with the firm's stability program. The company consistently failed to complete stability testing in a timely manner for several batches of Bulk API. This indicates a failure to follow their own standard operating procedures for administering a stability program.

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## Related Officers

- [Chemist](https://www.keypedia.com/people/tonya-r-johnson/403d3eb6-758b-4c57-80cf-901359382588)
- [Account Director](https://www.keypedia.com/people/stacie-a-woods/75a78a01-422e-4c6a-b7ac-b858354264ae)

Company: https://www.keypedia.com/companies/biovectra-inc/1e29a998-319e-49cb-bee2-bacea2c620ef

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd