FDA Intel

Abbott Nutrition

Form 483 issued September 24, 2021 · Sturgis, Michigan

Inspection
Sep 20 – Sep 24, 2021
Investigators
Daniel B. Arrecis· Elizabeth P. Mayer
Observations
5
Pages
4
FEI number
1815692

In short: On September 24, 2021, FDA issued a Form 483 with 5 observations to Abbott Nutrition in Sturgis, Michigan (FEI 1815692) after an inspection that ran Sep 20 – Sep 24, 2021. The investigators were Daniel B. Arrecis and Elizabeth P. Mayer. The most-cited regulation is 21 CFR 106.30 (controls to prevent adulteration caused by equipment or utensils).

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 106.20(a)

    You did not maintain a building used in the manufacture, processing, packing or holding of infant…

  2. 02
    21 CFR 106.30(g)

    You did not install a • · capable of b (4) when (b) (4) is used…

  3. 03
    21 CFR 106.10(b)(2)

    Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces…

  4. 04
    21 CFR 106.30(d)

    An instrument you used to measure, regulate, or control a processing parameter…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Abbott Nutrition history

All 11 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 106.20(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Abbott Nutrition?

FDA listed 5 observations on this Form 483. The most-cited regulation is 21 CFR 106.30 (controls to prevent adulteration caused by equipment or utensils). The opening words of each observation are shown on this page.

Who inspected Abbott Nutrition?

Daniel B. Arrecis and Elizabeth P. Mayer are named on this Form 483, for the inspection of Sep 20 – Sep 24, 2021. Each investigator has a profile showing what they cite most.

When was Abbott Nutrition inspected by FDA?

The inspection ran Sep 20 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.

How do I get the full Form 483 for Abbott Nutrition?

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