# FDA 483 - Catalent Ontario Limited - Unknown Date

Source: https://www.keypedia.com/records/483/catalent-ontario-limited/f82ffd90-6386-4c44-a6df-7e2b4dd98453

> FDA 483 for Catalent Ontario Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Ontario Limited
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Catalent Ontario, Limited, a manufacturing and analytical testing facility, revealed two significant issues related to record-keeping and sample retention for bioequivalence studies. The firm failed to retain reserve samples for reference products and lacked complete documentation for drug accountability of test and reference products used in studies. These observations indicate deficiencies in the firm's quality control and record management practices.

## Related Documents

- [483 - 2023-01-20](https://www.keypedia.com/records/483/catalent-ontario-limited/649f7db1-3206-4d9c-a64e-d6f1407bc4b9)
- [483 - 2023-01-20](https://www.keypedia.com/records/483/catalent-ontario-limited/bc9269fb-55da-4c79-9e30-2d8278f5d52e)

## Related Officers

- [investigator](https://www.keypedia.com/people/sripal-reddy-mada/5f6d3308-0728-4aa4-8a11-6b935c921643)

Company: https://www.keypedia.com/companies/catalent-ontario-limited/d28dfd20-1d16-4261-94e1-77497eb5150c

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321