# FDA 483 - Adamas Pharmaceuticals, Inc. - June 28, 2021

Source: https://www.keypedia.com/records/483/adamas-pharmaceuticals-inc/356317b2-dc31-4839-bb68-060cd9ae2817

> FDA 483 for Adamas Pharmaceuticals, Inc. on June 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adamas Pharmaceuticals, Inc.
- Inspection Date: 2021-06-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Adamas Pharmaceuticals, Inc. in Emeryville, CA, was inspected regarding its sponsor activities. The inspection revealed a significant deficiency in the firm's pharmacovigilance system, specifically the failure to develop and approve written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences. This lack of procedures, including for vendor oversight and reconciliation, potentially jeopardized patient health.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/adamas-pharmaceuticals-inc/b3c0a41e-8acd-4829-8f5d-00244c475ee8

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