# FDA 483 - SRI Healthcare, Llc - April 16, 2026

Source: https://www.keypedia.com/records/483/sri-healthcare-llc/b4ec6c78-5342-4295-800f-c582edc0b231

> FDA 483 for SRI Healthcare, Llc on April 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRI Healthcare, Llc
- Inspection Date: 2026-04-16
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA Form 483 was issued to SRI Healthcare, Llc in Mason, OH, following an inspection of their manufacturing facility. The inspection revealed two observations primarily concerning deficiencies in documentation practices and the quality management system. Specifically, the firm failed to document required infrastructure maintenance activities and did not conduct management reviews of the quality system at planned intervals.

## Related Officers

- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/sri-healthcare-llc/6b24abfd-5a8e-4757-9824-a90978e281c4

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