# FDA 483 - EKF Diagnostics, Inc. dba EFK Life Sciences - December 13, 2019

Source: https://www.keypedia.com/records/483/ekf-diagnostics-inc-dba-efk-life-sciences/05ecee85-9aff-4db0-a50b-c3ab38e1dbee

> FDA 483 for EKF Diagnostics, Inc. dba EFK Life Sciences on December 13, 2019. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EKF Diagnostics, Inc. dba EFK Life Sciences
- Inspection Date: 2019-12-13
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: EKF Diagnostics, Inc. dba EFK Life Sciences in Elkhart, IN was inspected from December 10-13, 2019. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and follow its own policies regarding preventive actions, risk analysis for product impact, and justification for extended completion dates for various actions.

## Related Documents

- [483 - 2022-11-09](https://www.keypedia.com/records/483/ekf-diagnostics-inc-dba-efk-life-sciences/fecf2d3f-e35c-4ada-941d-683e26e70692)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/ekf-diagnostics-inc-dba-efk-life-sciences/92731961-c3e8-4cec-bb06-e45b12bbe095

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0