# FDA 483 - CMP Pharma Inc - June 26, 2018

Source: https://www.keypedia.com/records/483/cmp-pharma-inc/2927d0d9-9a84-42dc-9147-5158673f4bdf

> FDA 483 for CMP Pharma Inc on June 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMP Pharma Inc
- Inspection Date: 2018-06-26
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of CMP Pharma Inc, a manufacturer in Farmville, NC, revealed significant deficiencies in their quality control unit and investigation procedures. The firm failed to complete required annual product reviews and lacked proper Quality/Supplier Agreements for contract laboratories. Additionally, their written investigation records were inadequate, with CAPA procedures missing effectiveness checks and deviation procedures lacking instructions for root cause analysis and historical reviews.

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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