Hill-Rom, Inc.
Form 483 issued January 11, 2013 · Batesville, Indiana
- Inspection
- Oct 29, 2012 – Jan 11, 2013
- Investigators
- Joseph R. Strelnik· Patrick B. Cummings· Sean T. Creighton
- Observations
- 11
- Pages
- 8
- FEI number
- 1824206
In short: On January 11, 2013, FDA issued a Form 483 with 11 observations to Hill-Rom, Inc. in Batesville, Indiana (FEI 1824206) after an inspection that ran Oct 29, 2012 – Jan 11, 2013. The investigators were Joseph R. Strelnik, Patrick B. Cummings and Sean T. Creighton. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and capa account for 8 of 11 observations.
Most cited: 21 CFR 820.30(f) (4×) · 820.60 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Procedures for corrective and preventive action have…
- 0421 CFR 820
Observation 4: scanned text, readable in the full document.
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmHill-Rom, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hill-Rom, Inc.?
FDA listed 11 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Hill-Rom, Inc.?
Joseph R. Strelnik, Patrick B. Cummings and Sean T. Creighton are named on this Form 483, for the inspection of Oct 29, 2012 – Jan 11, 2013. Each investigator has a profile showing what they cite most.
When was Hill-Rom, Inc. inspected by FDA?
The inspection ran Oct 29, 2012 – Jan 11, 2013, and the Form 483 is dated January 11, 2013.
How do I get the full Form 483 for Hill-Rom, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.