# FDA 483 - KDC/ONE Development Corporation, Inc. - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/kdcone-development-corporation-inc/88131bf2-1502-4b0e-8c39-a0ca93d71ae9

> FDA 483 for KDC/ONE Development Corporation, Inc. on January 27, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: KDC/ONE Development Corporation, Inc.
- Inspection Date: 2023-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: KDC/ONE Development Corporation, Inc. in Knowlton, a non-sterile contract drug manufacturer, was cited for deficiencies in laboratory record-keeping and production control procedures. Observations included a lack of proper documentation for test performance and unrecorded/unjustified deviations from written procedures during batch production. These issues indicate concerns with data integrity and adherence to established manufacturing processes.

## Related Documents

- [483 - 2017-09-21](https://www.globalkeysolutions.net/records/483/kdcone-development-corporation-inc/782048fe-ef3f-49e1-9613-1b0a8c71693e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

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

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