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Stuart Lee, Inc.

FDA Regulatory Profile

Stuart Lee, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Stuart Lee, Inc." and its spelling variants "Stuart Lee", "Stuart-Lee".

Latest inspection: Nov 7, 2014 · NAI
Latest 510(k): Jun 3, 1988

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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	1	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

Recent FDA inspections

2 inspections from Sep 28, 2010 to Nov 7, 2014.

Date	Site	Product	Classification	FEI
Nov 7, 2014	Old Lyme, CT	Devices	No Action Indicated (NAI)	1221661
Sep 28, 2010	Old Lyme, CT	Devices	No Action Indicated (NAI)	1221661

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1221661	Old Lyme, CT	2	Nov 7, 2014

Recent 510(k) clearances

1 510(k) clearance on Jun 3, 1988.

K-Number	Device	Date
K881741	STUART LEE CLIP	Jun 3, 1988

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