Abbott Nutrition
FDA inspection history in Sturgis, Michigan, 2008 to 2022
- 7
- EIRs
- 4
- Form 483s
Every document, by year
- Form 483
- EIR
2008: two inspection reports; 2009: one inspection report; 2010: one inspection report; 2015: one Form 483; 2018: one inspection report; 2019: one inspection report and one Form 483; 2021: one inspection report and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008–10Four inspection reports, at Sturgis, Michigan.
- 2015One Form 483, at Sturgis, Michigan.
- 2018–22Three inspection reports and three Form 483s, at Sturgis, Michigan.
- 2021The longest 483 on file: 5 observations over 4 pages at Sturgis, Michigan.
Cited most
Across all Abbott Nutrition observations on file
- 21 CFR 106.30(b)Controls to prevent adulteration caused by equipment or utensils4
- 21 CFR 106.10(b)(1)Controls to prevent adulteration by workers2
- 21 CFR 106.55(a)Controls to prevent adulteration from microorganisms2
- 21 CFR 110.80(a)(4)Processes and controls2
- 21 CFR 106.100(k)(2)Records1
The complete Abbott Nutrition file.
All 11 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Sturgis, Michigan
Seven inspection reports and four Form 483s · 2008 to 2022 · 13 observations
Latest: Form 483, Mar 18, 2022 →
Documents
11 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-18 | 483 Form 483 | Sturgis, Michigan | 4 | $99 |
| 2021-09-24 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2021-09-24 | 483 Form 483 | Sturgis, Michigan | 5 | $99 |
| 2019-09-24 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2019-09-24 | 483 Form 483 | Sturgis, Michigan | 1 | $99 |
| 2018-09-18 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2015-07-11 | 483 Form 483 | Sturgis, Michigan | 3 | $99 |
| 2010-03-24 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2009-02-13 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2008-10-16 | EIR EIR | Sturgis, Michigan | — | $550 |
| 2008-09-26 | EIR EIR | Sturgis, Michigan | — | $550 |
Investigators on these documents
Daniel B. Arrecis (5)Elizabeth P. Mayer (3)Tonnie L. Carter (3)Dariusz Galezowski (2)William D. Tingley (2)Danny Tuntevski (1)Eric M. Miller (1)Adam M. True (1)John N. Woodall (1)Kelley Clark (1)Liliya V. Bubiy (1)Margaret N. Persich (1)
FEI number 1815692 · most recent document Mar 18, 2022
About Abbott Nutrition
How many FDA Form 483s has Abbott Nutrition received?
FDA Intel has 4 Form 483s on file for Abbott Nutrition; the most recent is dated Mar 18, 2022.
When was Abbott Nutrition last inspected by FDA?
The most recent FDA inspection document on file for Abbott Nutrition is a Form 483 dated Mar 18, 2022, for the site in Sturgis, Michigan.
What did FDA cite at Abbott Nutrition?
The regulations cited most in the observations on file for Abbott Nutrition are 21 CFR 106.30(b) (Controls to prevent adulteration caused by equipment or utensils), 4 times; 21 CFR 106.10(b)(1) (Controls to prevent adulteration by workers), 2 times; 21 CFR 106.55(a) (Controls to prevent adulteration from microorganisms), 2 times.