# FDA 483 - Raptor Pharmaceuticals Inc. - August 24, 2016

Source: https://www.globalkeysolutions.net/records/483/raptor-pharmaceuticals-inc/841f35d6-c4e6-4deb-ba88-ee28ded0a6b9

> FDA 483 for Raptor Pharmaceuticals Inc. on August 24, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Raptor Pharmaceuticals Inc.
- Inspection Date: 2016-08-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Raptor Pharmaceuticals Inc., a drug manufacturer in Novato, CA, was inspected and cited for two significant issues. The firm failed to report twenty-seven serious and unexpected adverse drug experiences for its product PROCYSBI to the FDA within the required 15 calendar days. Additionally, their procedures for handling drug product complaints were found deficient, particularly concerning adverse events reported via social media and the lack of complaint trending.

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.globalkeysolutions.net/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.globalkeysolutions.net/companies/raptor-pharmaceuticals-inc/f87b9973-f35c-4df9-b7c5-f08b4a5c3eb9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b