# FDA 483 - Biovectra, Inc. - April 19, 2024

Source: https://www.globalkeysolutions.net/records/483/biovectra-inc/b779a428-d738-446c-9230-be96a523d76a

> FDA 483 for Biovectra, Inc. on April 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovectra, Inc.
- Inspection Date: 2024-04-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BioVectra, Inc. in Charlottetown, Canada, an API contract manufacturer, was cited for two significant deficiencies during an FDA inspection. The firm failed to follow written procedures for annual product reviews of Active Pharmaceutical Ingredients, a repeated deficiency, and lacked adequate laboratory controls to ensure API identity and quality, specifically regarding infrared spectroscopy testing. These issues indicate a breakdown in quality control and adherence to established standards.

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## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

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

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