# FDA 483 - C.P.M. Contract Pharma GmbH & Co. KG - July 05, 2019

Source: https://www.keypedia.com/records/483/cpm-contract-pharma-gmbh-co-kg/6fd7946e-91bc-4c43-b31d-dc7b2c589aab

> FDA 483 for C.P.M. Contract Pharma GmbH & Co. KG on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C.P.M. Contract Pharma GmbH & Co. KG
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: C.P.M. Contract Pharma GmbH & Co. KG was cited for significant deficiencies in their quality control systems during an FDA inspection. Observations included inadequate computer system controls for HPLC data integrity, deficient laboratory records lacking verification of electronic source data, and insufficient complaint handling procedures. Additionally, the firm failed to thoroughly review and timely close deviations related to unexplained discrepancies.

## Related Documents

- [WARNING_LETTER - 2014-01-14](https://www.keypedia.com/records/warning_letter/cpm-contract-pharma-gmbh-co-kg/eebe9c54-1262-414c-bbce-e272340d2b52)

## Related Officers

- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

Company: https://www.keypedia.com/companies/cpm-contract-pharma-gmbh-co-kg/603d56c1-f951-4a2d-9098-cd2fc6ee54f6

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1