# FDA 483 - Hill-Rom Inc - November 19, 2021

Source: https://www.keypedia.com/records/483/hill-rom-inc/15152261-1621-445a-ad09-58a26ad1c3e5

> FDA 483 for Hill-Rom Inc on November 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hill-Rom Inc
- Inspection Date: 2021-11-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Hill-Rom, Inc. in Batesville, IN, was cited for significant deficiencies in its quality system related to complaint handling and nonconforming product control. The inspection revealed that the firm failed to adequately investigate device complaints, often relying on insufficient prior investigations. Additionally, procedures for managing nonconforming materials did not define when investigations were necessary for newly identified defect types, posing potential risks to device quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2011-10-11](https://www.keypedia.com/records/warning_letter/hill-rom-inc/4c54f0ff-c285-427c-a357-2660fce27f69)
- [483 - 2013-01-11](https://www.keypedia.com/records/483/hill-rom-inc/9aaa4600-70f9-42a8-9c04-fc39d66cd5d3)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)
- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/hill-rom-inc/13baa578-a0c3-4149-b333-03ac13dae32b

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