Smiths Medical ASD Inc
Form 483 issued April 30, 2021 · Minneapolis, Minnesota
- Inspection
- Feb 23 – Apr 30, 2021
- Investigator
- Christina L. Bigham
- Observations
- 8
- Pages
- 14
- FEI number
- 3012307300
In short: On April 30, 2021, FDA issued a Form 483 with 8 observations to Smiths Medical ASD Inc in Minneapolis, Minnesota (FEI 3012307300) after an inspection that ran Feb 23 – Apr 30, 2021. The investigator was Christina L. Bigham. 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 8 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Procedures for collective and preventive action have…
- 03
Records of complaint investigations are not maintained by…
- 04
Procedures for design input have…
This inspection in context
Christina L. Bigham
11 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmSmiths Medical ASD Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Smiths Medical ASD Inc?
FDA listed 8 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Smiths Medical ASD Inc?
Christina L. Bigham is named on this Form 483, for the inspection of Feb 23 – Apr 30, 2021. Each investigator has a profile showing what they cite most.
When was Smiths Medical ASD Inc inspected by FDA?
The inspection ran Feb 23 – Apr 30, 2021, and the Form 483 is dated April 30, 2021.
How do I get the full Form 483 for Smiths Medical ASD 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.