Abbott Nutrition
Form 483 issued September 24, 2019 · Sturgis, Michigan
- Inspection
- Sep 16 – Sep 24, 2019
- Investigators
- Daniel B. Arrecis· Dariusz Galezowski
- Observations
- 1
- Pages
- 2
- FEI number
- 1815692
In short: On September 24, 2019, FDA issued a Form 483 with 1 observation to Abbott Nutrition in Sturgis, Michigan (FEI 1815692) after an inspection that ran Sep 16 – Sep 24, 2019. The investigators were Daniel B. Arrecis and Dariusz Galezowski. The most-cited regulation is 21 CFR 106.55 (controls to prevent adulteration from microorganisms).
What FDA observed
Preview: the opening words of each observation- 01
You did not test a representative sample of a production aggregate of a powdered infant formula…
This inspection in context
Daniel B. Arrecis
5 documents · 2019–2022
Cites 106.30(b) (controls to prevent adulteration caused by equipment or utensils) 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 106.55(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abbott Nutrition?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 106.55 (controls to prevent adulteration from microorganisms). The opening words of each observation are shown on this page.
Who inspected Abbott Nutrition?
Daniel B. Arrecis and Dariusz Galezowski are named on this Form 483, for the inspection of Sep 16 – Sep 24, 2019. Each investigator has a profile showing what they cite most.
When was Abbott Nutrition inspected by FDA?
The inspection ran Sep 16 – Sep 24, 2019, and the Form 483 is dated September 24, 2019.
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.