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

Source: https://www.keypedia.com/records/483/biovectra-inc/a9e6f5c1-5f2f-405e-8e41-a3422f6d1306

> 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 Pharmaceutical Quality Operations
- Summary: From August 22 to August 26, 2022, the U.S. Food and Drug Administration (FDA) conducted an inspection of BioVectra Inc., an active pharmaceutical ingredient manufacturer located in Charlottetown, Canada. The inspection identified two primary areas of concern regarding the facility's adherence to quality control and safety protocols. First, the firm failed to follow its own procedures for preventing microbiological contamination. Specifically, when air quality tests in a cleanroom showed particle levels exceeding safety thresholds on two occasions in early 2022, the company performed re-tests until passing results were obtained but neglected to conduct required investigations or risk assessments to determine the cause of the initial failures. Second, BioVectra did not adhere to its schedule for conducting annual quality reviews. A specific product review was found to be overdue, undermining the firm's ability to verify the ongoing consistency and quality of its manufacturing processes. Under the FDA's regulatory oversight, these observations represent potential violations of manufacturing standards. While the Form 483 does not constitute a final agency determination, BioVectra is expected to respond promptly. The company must provide a detailed plan for corrective actions, addressing how they will ensure future environmental monitoring excursions are investigated and that all quality reviews are completed according to their established master schedule.

## Related Documents

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- [483 - 2022-08-26](https://www.keypedia.com/records/483/biovectra-inc/e0f39d73-a345-4e14-9e5c-c2f807135e5d)
- [483 - 2024-04-19](https://www.keypedia.com/records/483/biovectra-inc/f876d21b-ffcd-4001-af36-2c6b587572d0)
- [483 - 2024-04-19](https://www.keypedia.com/records/483/biovectra-inc/b779a428-d738-446c-9230-be96a523d76a)

## 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-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe