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Synergy Health AST, LLC FDA Record

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

Synergy Health AST, LLC has 0 FDA recalls, 34 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Synergy Health AST, LLC" is on file.

What these totals cover: FDA records filed under the name "Synergy Health AST, LLC" and its spelling variant "Synergy Health Ast".

Latest inspection: Aug 11, 2026 · 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	34	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

Synergy Health AST, LLC'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	4	0	0	0	0
2025	2	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	2	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	3	0	0	0	0
2017	3	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

34 inspections from Nov 17, 2009 to Aug 11, 2026. Showing the 20 most recent. View all 34 inspections

Date	Site	Product	Classification	FEI
Aug 11, 2026	Petaluma, CA	Biologics	No Action Indicated (NAI)	3012102437
Jun 23, 2026	San Diego, CA	Biologics	No Action Indicated (NAI)	1000518731
May 21, 2026	Alajuela, Costa Rica	Devices	No Action Indicated (NAI)	3007738736
Mar 10, 2026	Saxonburg, PA	Biologics	No Action Indicated (NAI)	3009882464
Jun 6, 2025	Petaluma, CA	Drugs	Voluntary Action Indicated (VAI)	3012102437
Mar 21, 2025	Saxonburg, PA	Drugs	No Action Indicated (NAI)	3009882464
Jun 28, 2023	Petaluma, CA	Biologics	No Action Indicated (NAI)	3012102437
Jul 8, 2022	San Diego, CA	Drugs	No Action Indicated (NAI)	1000518731
May 26, 2022	Saxonburg, PA	Biologics	No Action Indicated (NAI)	3009882464
Jul 16, 2021	Saxonburg, PA	Devices	No Action Indicated (NAI)	3009882464
Aug 2, 2018	San Diego, CA	Biologics	No Action Indicated (NAI)	1000518731
Jul 27, 2018	Petaluma, CA	Biologics	No Action Indicated (NAI)	3012102437
Apr 30, 2018	Lima, OH	Drugs	No Action Indicated (NAI)	1000515342
Aug 2, 2017	Lima, OH	Devices	Voluntary Action Indicated (VAI)	1000515342
Jul 28, 2017	Petaluma, CA	Devices	No Action Indicated (NAI)	3012102437
Jan 25, 2017	Saxonburg, PA	Devices	No Action Indicated (NAI)	3009882464
Feb 29, 2016	San Diego, CA	Drugs	No Action Indicated (NAI)	1000518731
Jan 7, 2016	Saxonburg, PA	Biologics	No Action Indicated (NAI)	3009882464
Jul 13, 2015	Denver, CO	Devices	No Action Indicated (NAI)	3007496241
Jun 10, 2015	Lima, OH	Biologics	No Action Indicated (NAI)	1000515342

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

7 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3012102437	Petaluma, CA	5	Aug 11, 2026
FEI 1000518731	San Diego, CA	8	Jun 23, 2026
FEI 3007738736	Alajuela, Costa Rica	3	May 21, 2026
FEI 3009882464	Saxonburg, PA	7	Mar 10, 2026
FEI 1000515342	Lima, OH	6	Apr 30, 2018
FEI 3007496241	Denver, CO	4	Jul 13, 2015
FEI 3010273872	Alajuela, Costa Rica	1	Oct 23, 2014

Synergy Health AST, LLC and the FDA: common questions

Has Synergy Health AST, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Synergy Health AST, LLC" 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 Synergy Health AST, LLC received an FDA Form 483?

FDA has not published a Form 483 for "Synergy Health AST, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Synergy Health AST, LLC?

The most recent FDA inspection on file ended Aug 11, 2026 at Petaluma, CA and was classified NAI. FDA has 34 inspections of Synergy Health AST, LLC on file.

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