# FDA 483 - Purdue Pharma L.P. - October 05, 2023

Source: https://www.keypedia.com/records/483/purdue-pharma-lp/13b4c7ad-e4c7-4f1a-af57-992d0ae1df99

> FDA 483 for Purdue Pharma L.P. on October 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purdue Pharma L.P.
- Inspection Date: 2023-10-05
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Purdue Pharma L.P.'s corporate headquarters in Stamford, CT, revealed significant deficiencies in its post-marketing adverse drug experience reporting system. The firm lacked adequate written procedures for reporting non-15-day Alert reports and failed to submit thousands of serious and unexpected adverse drug experiences within the required 15 days. Additionally, individual adverse drug experiences were not consistently included in periodic safety reports, and numerous Individual Case Safety Reports (ICSRs) were submitted late.

## Related Documents

- [483 - 2019-03-29](https://www.keypedia.com/records/483/purdue-pharma-lp/6c6ff294-369e-4833-9071-4b0656b73654)

## Related Officers

- [investigator](https://www.keypedia.com/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.keypedia.com/companies/purdue-pharma-lp/12a191f7-7216-4b7c-aa90-a6e20688a346

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