# FDA 483 - Biovex, Inc. - February 13, 2015

Source: https://www.globalkeysolutions.net/records/483/biovex-inc/1a928e94-908a-40b7-94d7-cab746f2d60a

> FDA 483 for Biovex, Inc. on February 13, 2015. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biovex, Inc.
- Inspection Date: 2015-02-13
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of BioVex Inc., a biological drug substance and drug product manufacturer in Woburn, MA, identified three observations. These observations primarily concern deficiencies in aseptic manufacturing practices, including improper technique in a biological safety cabinet, inadequate documentation of logbook reviews, and failure to incorporate a validated hold period into media fill studies. The findings suggest issues with manufacturing controls and adherence to established procedures.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ramjay-vatsan/99fb6397-e539-41cb-a7c4-7ea9e7fafd5c)
- [Robin BALLICH](https://www.globalkeysolutions.net/people/robin-ballich/a062931a-3e5a-458d-bdbb-3cfa16629ff0)

Company: https://www.globalkeysolutions.net/companies/biovex-inc/796f9894-ce55-4789-9665-b70237ceb306

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