Abbott Diabetes Care, Inc
Form 483 issued October 22, 2015 · Alameda, California
- Inspection
- Oct 7 – Oct 22, 2015
- Investigator
- Maida Henesian
- Observations
- 3
- Pages
- 3
- FEI number
- 3002803444
In short: On October 22, 2015, FDA issued a Form 483 with 3 observations to Abbott Diabetes Care, Inc in Alameda, California (FEI 3002803444) after an inspection that ran Oct 7 – Oct 22, 2015. The investigator was Maida Henesian. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Personnel do not have the necessary training…
This inspection in context
Maida Henesian
3 documents · 2015–2023
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmAbbott Diabetes Care, 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 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abbott Diabetes Care, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Abbott Diabetes Care, Inc?
Maida Henesian is named on this Form 483, for the inspection of Oct 7 – Oct 22, 2015. Each investigator has a profile showing what they cite most.
When was Abbott Diabetes Care, Inc inspected by FDA?
The inspection ran Oct 7 – Oct 22, 2015, and the Form 483 is dated October 22, 2015.
How do I get the full Form 483 for Abbott Diabetes Care, 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.