# 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.

## Related Documents

- [483 - 2016-05-11](https://www.keypedia.com/records/483/cmp-pharma-inc/ab36b906-a96c-4256-ac74-f28a2964e6d5)
- [EIR - 2016-05-11](https://www.keypedia.com/records/eir/cmp-pharma-inc/f9aa359e-4ab4-4b94-bb26-1ac0f5169bdd)
- [EIR - 2016-12-21](https://www.keypedia.com/records/eir/cmp-pharma-inc/cb9859dd-47d5-449e-8381-beff6533613d)
- [EIR - 2017-05-25](https://www.keypedia.com/records/eir/cmp-pharma-inc/cea15463-7e87-457c-b20d-8f811db7003a)
- [483 - 2018-06-26](https://www.keypedia.com/records/483/cmp-pharma-inc/2927d0d9-9a84-42dc-9147-5158673f4bdf)

## 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