# FDA 483 - Louisville APL Diagnostics, Inc. - December 19, 2022

Source: https://www.globalkeysolutions.net/records/483/louisville-apl-diagnostics-inc/e86d2ccd-3994-4568-8390-04ad4fa091c0

> FDA 483 for Louisville APL Diagnostics, Inc. on December 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Louisville APL Diagnostics, Inc.
- Inspection Date: 2022-12-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Louisville APL Diagnostics, Inc., a medical device manufacturer in Texas City, TX, was inspected by the FDA from December 14-19, 2022. The inspection revealed significant deficiencies in labeling control, complaint handling procedures, and design validation documentation. These issues indicate a need for improved quality system compliance.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/louisville-apl-diagnostics-inc/40244cc1-a098-48d3-9ca2-7eb649e56a65

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab