# FDA 483 - Viva Pharmaceutical Inc - October 25, 2024

Source: https://www.keypedia.com/records/483/viva-pharmaceutical-inc/1045a00a-c3b3-4811-98aa-88f00296395e

> FDA 483 for Viva Pharmaceutical Inc on October 25, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Viva Pharmaceutical Inc
- Inspection Date: 2024-10-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Viva Pharmaceutical Inc. in Richmond, British Columbia, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included inadequate equipment cleaning, critical failures in the quality control unit's data integrity and oversight, and insufficient investigations into out-of-specification results. Additionally, the facility showed poor maintenance with damaged production room flooring.

## Related Documents

- [483 - 2020-01-10](https://www.keypedia.com/records/483/viva-pharmaceutical-inc/20070fe9-ba39-4681-ae55-addb04872efc)
- [483 - 2024-10-25](https://www.keypedia.com/records/483/viva-pharmaceutical-inc/2cf44d25-d1bf-495f-9697-b393abdbf46e)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/viva-pharmaceutical-inc/0e5d1aa3-8369-4a0d-91b7-e516415fb219

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8