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Oatly

FDA Regulatory Profile

Oatly has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Oatly".

Latest inspection: Jan 17, 2024 · NAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA Record by Year

Oatly's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA Inspections

2 inspections from Dec 11, 2019 to Jan 17, 2024.

Date	Site	Product	Classification	FEI
Jan 17, 2024	New York, NY	Food/Cosmetics	No Action Indicated (NAI)	3014146989
Dec 11, 2019	Millville, NJ	Food/Cosmetics	No Action Indicated (NAI)	3014773737

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3014146989	New York, NY	1	Jan 17, 2024
FEI 3014773737	Millville, NJ	1	Dec 11, 2019

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