# FDA 483 - CMP Pharma Inc - December 21, 2016

Source: https://www.keypedia.com/records/483/cmp-pharma-inc/e0d9c652-ef72-4a17-abbb-6e547f567f1d

> FDA 483 for CMP Pharma Inc on December 21, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMP Pharma Inc
- Inspection Date: 2016-12-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: CMP Pharma Inc, a drug manufacturer in Farmville, NC, received a Form 483 with two observations concerning its post-marketing adverse drug experience (ADE) reporting. The firm failed to report individual ADEs to the FDA in 15-day alerts and include them in periodic safety reports, and its written procedures for handling post-marketing ADEs were found to be inadequate. These deficiencies highlight significant issues in the firm's pharmacovigilance system.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/cmp-pharma-inc/dfe75ec5-dd7b-4835-a28a-178b728ddb2c

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7