Abbott Nutrition
Form 483 issued March 18, 2022 · Sturgis, Michigan
- Inspection
- Jan 31 – Mar 16, 2022
- Investigators
- Adam M. True· Alexandra A. Carrico· Ana E. Morales
- Observations
- 4
- Pages
- 10
- FEI number
- 1815692
In short: On March 18, 2022, FDA issued a Form 483 with 4 observations to Abbott Nutrition in Sturgis, Michigan (FEI 1815692) after an inspection that ran Jan 31 – Mar 16, 2022. The investigators were Adam M. True, Alexandra A. Carrico, Ana E. Morales, Brittany A. McKenzie, Christi L. Bellmore, Daniel B. Arrecis, Danny Tuntevski, Elizabeth P. Mayer, John N. Woodall, Liliya V. Bubiy, Nicholas E. Boyd and Rohn R. Robertson.
What FDA observed
Preview: the opening words of each observation- 01
You did not establish a system of process controls covering all stages of processing that was…
- 02
You did not ensure that all surfaces that contacted infant formula were maintained to protect infant…
- 0321 CFR 106.100(k)(2)
Your investigation file on a complaint did not include the determination as to whether a hazard…
- 04
Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces…
This inspection in context
Adam M. True
1 document · 2022
Cites 106.10(b)(1) (controls to prevent adulteration by workers) 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Abbott Nutrition?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Abbott Nutrition?
Adam M. True, Alexandra A. Carrico, Ana E. Morales, Brittany A. McKenzie, Christi L. Bellmore, Daniel B. Arrecis, Danny Tuntevski, Elizabeth P. Mayer, John N. Woodall, Liliya V. Bubiy, Nicholas E. Boyd and Rohn R. Robertson are named on this Form 483, for the inspection of Jan 31 – Mar 16, 2022. Each investigator has a profile showing what they cite most.
When was Abbott Nutrition inspected by FDA?
The inspection ran Jan 31 – Mar 16, 2022, and the Form 483 is dated March 18, 2022.
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.