Hill-Rom Inc – FDA 483, Jan 11, 2013

The FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in the facility's quality system and manufacturing processes for various medical beds (TotalCare, VersaCare, GPAC, Resident, Affinity).

**Key Violations and Observations:**

* **Complaint Handling (21 CFR 820.198):** The complaint handling system is inadequate. From 10/01/2011 to 10/26/2012, 563 complaints involving component failures within 14 days of distribution, 384 TotalCare graphic user interface failures, and 603 TotalCare power control module failures were not investigated, despite the procedure requiring investigation for device failures. * **Control of Nonconforming Product (21 CFR 820.90):** Procedures for controlling nonconforming product are inadequate. Six nonconforming beds (5 TotalCare, 1 VersaCare) were found in a Research and Development area, not a designated quarantined area, making it impossible to distinguish them from R&D or returned units. Several of these beds had multiple final inspection failures but were released for distribution, only to fail product audits. Additionally, nonconformance documentation for 1,986 in-line nonconformances from 10/01/2011 to 10/26/2012 lacked