# FDA 483 - CMP Pharma Inc - May 11, 2016

Source: https://www.globalkeysolutions.net/records/483/cmp-pharma-inc/ab36b906-a96c-4256-ac74-f28a2964e6d5

> FDA 483 for CMP Pharma Inc on May 11, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMP Pharma Inc
- Inspection Date: 2016-05-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of CMP Pharma Inc, a drug manufacturer in Farmville, NC, revealed four observations concerning deficiencies in their quality systems. These included inadequate laboratory controls for expiration and retest dating, failure to consistently follow quality control unit procedures for SOP reviews, and incomplete documentation for investigations into discrepancies. Additionally, the firm lacked approved written procedures for the operation of a weight checker used for unit dose products.

## Related Documents

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## Related Officers

- [Seneca D Romo](https://www.globalkeysolutions.net/people/seneca-d-romo/2938acb3-e219-4c00-b809-40648b38c054)
- [Investigator](https://www.globalkeysolutions.net/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

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

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