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SWISSCAPS Romania SRL FDA Record

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

Latest inspection VAI · Oct 11, 2024
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

SWISSCAPS Romania SRL has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SWISSCAPS Romania SRL" is on file.

What these totals cover: FDA records filed under the name "SWISSCAPS Romania SRL" and its spelling variant "Swisscaps Romania".

Latest inspection: Oct 11, 2024 · 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	5	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

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

SWISSCAPS Romania SRL: 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	2	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	1	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.

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Recent FDA inspections

5 inspections from Feb 19, 2016 to Oct 11, 2024.

Date	Site	Product	Classification	FEI
Oct 11, 2024	Cornu, Romania	Drugs	Voluntary Action Indicated (VAI)	2000030299
Aug 27, 2024	Cornu, Romania	Food/Cosmetics	No Action Indicated (NAI)	2000030299
Aug 21, 2019	Cornu, Romania	Food/Cosmetics	Voluntary Action Indicated (VAI)	2000030299
May 11, 2018	Cornu, Romania	Drugs	Voluntary Action Indicated (VAI)	2000030299
Feb 19, 2016	Cornu, Romania	Drugs	Voluntary Action Indicated (VAI)	2000030299

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 2000030299	Cornu, Romania	5	Oct 11, 2024

SWISSCAPS Romania SRL and the FDA: common questions

Has SWISSCAPS Romania SRL received an FDA warning letter?

No FDA warning letter addressed to the name "SWISSCAPS Romania SRL" 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 SWISSCAPS Romania SRL received an FDA Form 483?

FDA has not published a Form 483 for "SWISSCAPS Romania SRL" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect SWISSCAPS Romania SRL?

The most recent FDA inspection on file ended Oct 11, 2024 at Cornu, Romania and was classified VAI. FDA has 5 inspections of SWISSCAPS Romania SRL on file.

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