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Coopervision Manufacturing, Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Jan 17, 2019
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Coopervision Manufacturing, Ltd. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Coopervision Manufacturing, Ltd." is on file.

What these totals cover: FDA records filed under the name "Coopervision Manufacturing, Ltd." and its spelling variant "Coopervision Manufacturing".

Latest inspection: Jan 17, 2019 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Coopervision Manufacturing, Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	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	1	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.

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Recent FDA inspections

7 inspections from Apr 15, 2010 to Jan 17, 2019.

Date	Site	Product	Classification	FEI
Jan 17, 2019	Eastleigh, United Kingdom	Devices	No Action Indicated (NAI)	3003981983
Jan 19, 2017	Eastleigh, United Kingdom	Devices	No Action Indicated (NAI)	3003981983
Sep 4, 2015	Southampton, United Kingdom	Devices	No Action Indicated (NAI)	3002806417
Sep 3, 2015	Fareham, United Kingdom	Devices	No Action Indicated (NAI)	3006514242
Dec 5, 2013	Eastleigh, United Kingdom	Devices	Voluntary Action Indicated (VAI)	3003981983
Apr 22, 2010	Fareham, United Kingdom	Devices	Voluntary Action Indicated (VAI)	3006514242
Apr 15, 2010	Southampton, United Kingdom	Devices	Voluntary Action Indicated (VAI)	3002806417

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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003981983	Eastleigh, United Kingdom	3	Jan 17, 2019
FEI 3002806417	Southampton, United Kingdom	2	Sep 4, 2015
FEI 3006514242	Fareham, United Kingdom	2	Sep 3, 2015

Coopervision Manufacturing, Ltd. and the FDA: common questions

Has Coopervision Manufacturing, Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Coopervision Manufacturing, Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Coopervision Manufacturing, Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Coopervision Manufacturing, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Coopervision Manufacturing, Ltd.?

The most recent FDA inspection on file ended Jan 17, 2019 at Eastleigh, United Kingdom and was classified NAI. FDA has 7 inspections of Coopervision Manufacturing, Ltd. on file.

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