# FDA 483 - Novocol Pharmaceutical of Canada, Inc. - June 18, 2019

Source: https://www.globalkeysolutions.net/records/483/novocol-pharmaceutical-of-canada-inc/7485559c-7f8a-451d-a20e-1683858db483

> FDA 483 for Novocol Pharmaceutical of Canada, Inc. on June 18, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novocol Pharmaceutical of Canada, Inc.
- Inspection Date: 2019-06-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Novocol Pharmaceutical of Canada, Inc. was cited for three observations during an FDA inspection. The firm failed to follow established procedures for preventing microbiological contamination of sterile drug products, including visual inspection qualification and semi-automated inspection protocols. Additionally, the company did not properly document and evaluate recurring priority 1 alarms as required by its alarm response procedure.

## Related Officers

- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

Company: https://www.globalkeysolutions.net/companies/novocol-pharmaceutical-of-canada-inc/28ac0d84-7b4b-4be0-96a8-9daeafbb5ac3

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