# FDA 483 - Biovectra, Inc. - August 26, 2022

Source: https://www.keypedia.com/records/483/biovectra-inc/e0f39d73-a345-4e14-9e5c-c2f807135e5d

> FDA 483 for Biovectra, Inc. on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovectra, Inc.
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of BioVectra Inc., an Active Pharmaceutical Ingredient manufacturer in Charlottetown, Canada, revealed two significant observations. The firm failed to consistently follow procedures for environmental monitoring, specifically regarding non-viable particulate excursions in a cleanroom. Additionally, the company did not adhere to its master schedule for completing annual product reviews for Active Pharmaceutical Ingredients.

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## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

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

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