# FDA WARNING_LETTER - Hill-Rom Inc - October 11, 2011

Source: https://www.keypedia.com/records/warning_letter/hill-rom-inc/4c54f0ff-c285-427c-a357-2660fce27f69

> FDA WARNING_LETTER for Hill-Rom Inc on October 11, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Hill-Rom Inc
- Inspection Date: 2011-10-11
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: On March 2, 2012, the FDA issued a Warning Letter to Hill-Rom, Inc. following an inspection from September 20 to October 11, 2011, at their Batesville, Indiana facility. The inspection found that the firm's AC-Powered Patient Lifts and AC-Powered Adjustable Hospital Beds were adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Design Verification (21 CFR 820.30(f)):** Failure to adequately verify device design, with design verification activities not confirming design output met input requirements, incomplete traceability summaries, and inadequate objective evidence for design requirement specifications.
2.  **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)):** Inadequate CAPA system, exemplified by 336 VersaCare bed battery failures without investigation or corrective action, and improper trending of discontinued components.
3.  **Process Validation (21 CFR 820.75(a)):** Failure to fully validate automated/semi-automated processes for VersaCare beds, with an inadequate validation procedure only allowing periodic monitoring instead of full validation.
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## Related Documents

- [483 - 2013-01-11](https://www.keypedia.com/records/483/hill-rom-inc/9aaa4600-70f9-42a8-9c04-fc39d66cd5d3)
- [483 - 2021-11-19](https://www.keypedia.com/records/483/hill-rom-inc/15152261-1621-445a-ad09-58a26ad1c3e5)

## Related Officers

- [Keith Jasukaitis](https://www.keypedia.com/people/keith-jasukaitis/0944ea7d-e874-476a-94ed-07905d2788c4)
- [Michael J. Murphy](https://www.keypedia.com/people/michael-j-murphy/1154f8b3-b9d4-4ba1-93b8-ed248d93e1a1)
- [Director](https://www.keypedia.com/people/glenn-t-bass/6b38b304-c54b-41db-b7bb-e777e6dc4bce)
- [Kimberly Y. Martin](https://www.keypedia.com/people/kimberly-y-martin/f71bec7b-eee4-440f-ab86-796a50db45e5)

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

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03