# FDA 483 - Partner Therapeutics, Inc. - September 16, 2022

Source: https://www.keypedia.com/records/483/partner-therapeutics-inc/d0f4053c-58c5-4e76-8dea-035109e87090

> FDA 483 for Partner Therapeutics, Inc. on September 16, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Partner Therapeutics, Inc.
- Inspection Date: 2022-09-16
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of PARTNER THERAPEUTICS INC in Lexington, MA, revealed significant deficiencies in their adverse event reporting processes. The firm failed to report serious and unexpected adverse experiences from a postmarketing clinical study within the required timeframe, including cases where the investigator assessed a reasonable possibility of relatedness. Additionally, there was a lack of documentation for unsuccessful attempts to seek additional information regarding serious and unexpected adverse experiences, contrary to their own standard operating procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/yvette-m-lacour-davis/8bae7c3f-2c46-4bf0-9e77-beaa25cdad91)

Company: https://www.keypedia.com/companies/partner-therapeutics-inc/02b6f3e3-ef3e-4352-9f94-1e462de5f2b4

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94