# FDA EIR - CMP Pharma Inc - May 25, 2017

Source: https://www.keypedia.com/records/eir/cmp-pharma-inc/cea15463-7e87-457c-b20d-8f811db7003a

> FDA EIR for CMP Pharma Inc on May 25, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: CMP Pharma Inc
- Inspection Date: 2017-05-25
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of CMP Pharma Inc. (CMPPI) was conducted on May 25, 2017, specifically targeting the company's quality system for Class I enema kits. This inspection marked CMPPI's first under the regulatory framework of CP 7382.845, "Inspection of Medical Device Manufacturers," covering Management Controls, CAPA, and Purchasing & Production Controls subsystems. Notably, no FDA-483, Inspectional Observations, were issued, indicating the absence of formal violations. However, the inspection did identify two areas for improvement during the close-out discussion. Management acknowledged the need to establish specific training procedures for employees tailored to medical device manufacturing regulations, as current training was based on drug manufacturing Good Manufacturing Practices (GMPs). Additionally, there was a recognized lack of management awareness regarding Unique Device Identifier (UDI) compliance for the enema kits. As a required action, the Director of Quality Assurance committed to contacting the enema kit manufacturer to clarify UDI compliance. Management promised to implement the discussed corrections.

## 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)
- [483 - 2016-12-21](https://www.keypedia.com/records/483/cmp-pharma-inc/e0d9c652-ef72-4a17-abbb-6e547f567f1d)
- [EIR - 2016-12-21](https://www.keypedia.com/records/eir/cmp-pharma-inc/cb9859dd-47d5-449e-8381-beff6533613d)
- [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/perry-h-gambrell/8f9779d8-0cf9-402a-9fdb-bfd08bd8ccf8)

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