# FDA 483 - KDC/ONE Development Corporation, Inc. - September 21, 2017

Source: https://www.globalkeysolutions.net/records/483/kdcone-development-corporation-inc/782048fe-ef3f-49e1-9613-1b0a8c71693e

> FDA 483 for KDC/ONE Development Corporation, Inc. on September 21, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KDC/ONE Development Corporation, Inc.
- Inspection Date: 2017-09-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection from September 18-21, 2017, Les Emballages Knowlton Inc. in Knowlton, Quebec, Canada, was cited for deficiencies related to laboratory records and data integrity. Observations included incomplete data from tests due to unvalidated software lacking an audit trail, and inadequate review of electronic raw data for finished product release.

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## Related Officers

- [Emily J. Orban](https://www.globalkeysolutions.net/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

Company: https://www.globalkeysolutions.net/companies/kdcone-development-corporation-inc/3906f0b9-88a3-4c11-9833-e76f5df83b49

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd