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Syneos Health Clinique, Inc. FDA Record

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

Latest inspection NAI · Sep 12, 2025
No warning letters matched by name

Inspections 6

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Syneos Health Clinique, Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Syneos Health Clinique, Inc." is on file.

What these totals cover: FDA records filed under the name "Syneos Health Clinique, Inc." and its spelling variant "Syneos Health Clinique".

Latest inspection: Sep 12, 2025 · NAI

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	6	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

Syneos Health Clinique, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Syneos Health Clinique, Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	4	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.

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Recent FDA inspections

6 inspections from Jun 14, 2019 to Sep 12, 2025.

Date	Site	Product	Classification	FEI
Sep 12, 2025	Quebec, Canada	Drugs	No Action Indicated (NAI)	3002533384
Jan 27, 2023	Quebec, Canada	Drugs	No Action Indicated (NAI)	3002533384
Dec 13, 2019	Quebec, Canada	Drugs	No Action Indicated (NAI)	3002533384
Jul 30, 2019	Montreal, Canada	Drugs	No Action Indicated (NAI)	3003974218
Jun 28, 2019	Quebec, Canada	Drugs	No Action Indicated (NAI)	3002533384
Jun 14, 2019	Quebec, Canada	Drugs	No Action Indicated (NAI)	3002533384

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 3002533384	Quebec, Canada	5	Sep 12, 2025
FEI 3003974218	Montreal, Canada	1	Jul 30, 2019

Syneos Health Clinique, Inc. and the FDA: common questions

Has Syneos Health Clinique, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Syneos Health Clinique, Inc." 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 Syneos Health Clinique, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Syneos Health Clinique, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Syneos Health Clinique, Inc.?

The most recent FDA inspection on file ended Sep 12, 2025 at Quebec, Canada and was classified NAI. FDA has 6 inspections of Syneos Health Clinique, Inc. on file.

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