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MeKo Manufacturing E.K. FDA Record

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

MeKo Manufacturing E.K. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "MeKo Manufacturing E.K." is on file.

What these totals cover: FDA records filed under the name "MeKo Manufacturing E.K." and its spelling variant "Meko Manufacturing E.K".

Latest inspection: Feb 21, 2019 · VAI

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	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

MeKo Manufacturing E.K.'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	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

3 inspections from Feb 11, 2016 to Feb 21, 2019.

Date	Site	Product	Classification	FEI
Feb 21, 2019	Sarstedt, Germany	Devices	Voluntary Action Indicated (VAI)	3009937642
Jan 6, 2017	Sarstedt, Germany	Devices	No Action Indicated (NAI)	3009937642
Feb 11, 2016	Sarstedt, Germany	Devices	Official Action Indicated (OAI)	3009937642

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 3009937642	Sarstedt, Germany	3	Feb 21, 2019

MeKo Manufacturing E.K. and the FDA: common questions

Has MeKo Manufacturing E.K. received an FDA warning letter?

No FDA warning letter addressed to the name "MeKo Manufacturing E.K." 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 MeKo Manufacturing E.K. received an FDA Form 483?

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

When did the FDA last inspect MeKo Manufacturing E.K.?

The most recent FDA inspection on file ended Feb 21, 2019 at Sarstedt, Germany and was classified VAI. FDA has 3 inspections of MeKo Manufacturing E.K. on file, 1 of them classified OAI (official action indicated).

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