# FDA 483 - LH Medical Corporation - March 19, 2020

Source: https://www.keypedia.com/records/483/lh-medical-corporation/c157f5d1-52b7-482d-8ee2-f63e1cc1e5e8

> FDA 483 for LH Medical Corporation on March 19, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LH Medical Corporation
- Inspection Date: 2020-03-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: This FDA Form 483 report details significant quality system deficiencies observed at LH Medical Corporation in Fort Wayne, IN, a contract manufacturer. The inspection revealed inadequate procedures for handling customer complaints, acceptance activities, process controls, and corrective and preventive actions. Additionally, the firm failed to provide adequate data for process validation, indicating a broad lack of control over critical manufacturing processes.

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/lh-medical-corporation/d0dbc87c-7ecb-4b1f-a3a1-53f73c588c02

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