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Keystone Mills, LLC

FDA Regulatory Profile

Keystone Mills, LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Keystone Mills, LLC" and its spelling variant "Keystone Mills".

Latest inspection: Jul 15, 2026 · 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	7	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

Keystone Mills, LLC'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	2	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	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

7 inspections from Feb 25, 2009 to Jul 15, 2026.

Date	Site	Product	Classification	FEI
Jul 15, 2026	Romulus, NY	Veterinary	No Action Indicated (NAI)	1319306
Jul 15, 2026	Romulus, NY	Veterinary	No Action Indicated (NAI)	3013137296
Mar 28, 2022	Romulus, NY	Veterinary	Voluntary Action Indicated (VAI)	1319306
May 18, 2021	Romulus, NY	Veterinary	No Action Indicated (NAI)	3013137296
Jul 28, 2016	Romulus, NY	Veterinary	Voluntary Action Indicated (VAI)	1319306
Feb 4, 2010	Romulus, NY	Veterinary	No Action Indicated (NAI)	1319306
Feb 25, 2009	Romulus, NY	Veterinary	No Action Indicated (NAI)	1319306

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: 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 1319306	Romulus, NY	5	Jul 15, 2026
FEI 3013137296	Romulus, NY	2	Jul 15, 2026

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