Abbott Nutrition
Form 483 issued July 11, 2015 · Sturgis, Michigan
- Inspection
- Sep 20 – Oct 22, 2010
- Investigators
- Eric M. Miller· Tonnie L. Carter
- Observations
- 3
- Pages
- 3
- FEI number
- 1815692
In short: On July 11, 2015, FDA issued a Form 483 with 3 observations to Abbott Nutrition in Sturgis, Michigan (FEI 1815692) after an inspection that ran Sep 20 – Oct 22, 2010. The investigators were Eric M. Miller and Tonnie L. Carter. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
3 of 3 observations on this 483 concern food cgmp / preventive controls.
What FDA observed
Preview: the opening words of each observation- 01
Failure to manufacture foods under conditions and controls…
- 02
Effective measures aye not being taken to exclude pests…
- 03
There is no assurance that raw materials which are susceptible to contamination with extraneous materials comply…
This inspection in context
Eric M. Miller
2 documents · 2012–2015
Cites 110.80(a)(4) (processes and controls) more than any other section. Most of their documents are for sites in Michigan.
The firmAbbott Nutrition history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.80(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abbott Nutrition?
FDA listed 3 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.
Who inspected Abbott Nutrition?
Eric M. Miller and Tonnie L. Carter are named on this Form 483, for the inspection of Sep 20 – Oct 22, 2010. Each investigator has a profile showing what they cite most.
When was Abbott Nutrition inspected by FDA?
The inspection ran Sep 20 – Oct 22, 2010, and the Form 483 is dated July 11, 2015.
How do I get the full Form 483 for Abbott Nutrition?
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.