# FDA 483 - Purdue Pharmaceuticals LP - December 19, 2019

Source: https://www.keypedia.com/records/483/purdue-pharmaceuticals-lp/40ab1419-91d2-40cf-ac2f-92c939187f63

> FDA 483 for Purdue Pharmaceuticals LP on December 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Purdue Pharmaceuticals LP
- Inspection Date: 2019-12-19
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Purdue Pharmaceuticals Lp, a narcotics drug products manufacturer in Wilson, NC, was cited for significant deficiencies in its investigation processes. The firm failed to thoroughly assess and address unexplained discrepancies, out-of-specification results, potential contamination sources, and consumer complaints. These issues indicate a systemic problem with the company's quality control and corrective action procedures.

## Related Documents

- [483 - 2022-08-11](https://www.keypedia.com/records/483/purdue-pharmaceuticals-lp/372c0650-56a8-4ac0-b1ec-b6acca464f95)

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/purdue-pharmaceuticals-lp/404112a8-6b5a-4bea-9890-9c5f6339ca44

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9