# FDA 483 - Sterinova Inc. - September 07, 2022

Source: https://www.globalkeysolutions.net/records/483/sterinova-inc/9795a588-f782-48e3-8516-8e4129af0ea4

> FDA 483 for Sterinova Inc. on September 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterinova Inc.
- Inspection Date: 2022-09-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sterinova Inc., a sterile drug product manufacturer in Saint-Hyacinthe, revealed significant deficiencies in aseptic processing. Observations included failures in sterile gowning procedures and personnel monitoring, as well as inadequate cleaning and disinfection processes within Restricted Access Barrier Systems (RABS). These issues indicate a lack of control over microbiological contamination and aseptic conditions.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sterinova-inc/e65fc0f0-8467-4083-98ff-184c7df042a3

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