# FDA 483 - Catalent Ontario Limited - May 02, 2025

Source: https://www.globalkeysolutions.net/records/483/catalent-ontario-limited/95b0ced5-5419-4ebc-8b2f-502271d9c5d4

> FDA 483 for Catalent Ontario Limited on May 02, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Ontario Limited
- Inspection Date: 2025-05-02
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Catalent Ontario Limited, a human and veterinary drug product manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures to thoroughly investigate discrepancies and batch failures, inadequate equipment cleaning and maintenance leading to contamination, and poorly designed equipment. Additionally, master production records were incomplete, and written procedures for production and process controls, such as hand hygiene, were found to be insufficient.

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.globalkeysolutions.net/companies/catalent-ontario-limited/0d441910-9eee-4011-b5e8-c989fb788c69

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