# FDA 483 - Life Sciences Vandalia - September 06, 2024

Source: https://www.keypedia.com/records/483/life-sciences-vandalia/77882ed6-a808-4630-a818-5a06c0453254

> FDA 483 for Life Sciences Vandalia on September 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Sciences Vandalia
- Inspection Date: 2024-09-06
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Life Sciences Vandalia in Dayton, OH, revealed significant deficiencies in their quality system for manufacturing implantable devices. Observations included inadequate maintenance of complaint files, insufficient documentation of corrective and preventive actions, and a lack of proper evaluation and documentation for out-of-calibration equipment. These issues indicate a potential impact on product quality and patient safety.

## Related Officers

- [Talmane J. Fisher](https://www.keypedia.com/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.keypedia.com/companies/life-sciences-vandalia/7ab02146-1fa0-4c71-9e0d-a712fb5a7815

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22