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Xytex Laboratories

FDA Regulatory Profile

Xytex Laboratories has 0 FDA recalls, 20 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Xytex Laboratories".

Latest inspection
May 6, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections20Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Xytex Laboratories: FDA inspections per year 2017: 0 inspections020172018: 2 inspections220182019: 1 inspections120192020: 0 inspections020202021: 1 inspections120212022: 3 inspections320222023: 1 inspections120232024: 4 inspections420242025: 1 inspections120252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202510000
202440000
202310000
202230000
202110000
202000000
201910000
201820000
201700000

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.

Recent FDA inspections

20 inspections from Nov 17, 2010 to May 6, 2026.

DateSiteProductClassificationFEI
May 6, 2026Augusta, GABiologicsNo Action Indicated (NAI)1000507143
Nov 19, 2025Lawrenceville, GABiologicsNo Action Indicated (NAI)3030249523
Sep 5, 2024Athens, GABiologicsNo Action Indicated (NAI)3014254056
Jul 25, 2024Marietta, GABiologicsNo Action Indicated (NAI)3017451050
Jul 23, 2024Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Jun 26, 2024Charlotte, NCBiologicsNo Action Indicated (NAI)3019356415
Jul 11, 2023Augusta, GABiologicsNo Action Indicated (NAI)1000507143
Aug 5, 2022Athens, GABiologicsNo Action Indicated (NAI)3014254056
Jul 26, 2022Charlotte, NCBiologicsNo Action Indicated (NAI)3019356415
Jul 13, 2022Marietta, GABiologicsNo Action Indicated (NAI)3017451050
Sep 2, 2021Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Feb 21, 2019Augusta, GABiologicsNo Action Indicated (NAI)1000507143
Dec 21, 2018Athens, GABiologicsVoluntary Action Indicated (VAI)3014254056
Sep 21, 2018Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Feb 2, 2016Augusta, GABiologicsNo Action Indicated (NAI)1000507143
Jan 14, 2016Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Nov 16, 2015Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Dec 3, 2013Augusta, GABiologicsNo Action Indicated (NAI)1000507143
Mar 7, 2011Atlanta, GABiologicsNo Action Indicated (NAI)3003420280
Nov 17, 2010Augusta, GABiologicsNo Action Indicated (NAI)1000507143
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

6 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1000507143Augusta, GA6May 6, 2026
FEI 3030249523Lawrenceville, GA1Nov 19, 2025
FEI 3014254056Athens, GA3Sep 5, 2024
FEI 3017451050Marietta, GA2Jul 25, 2024
FEI 3003420280Atlanta, GA6Jul 23, 2024
FEI 3019356415Charlotte, NC2Jun 26, 2024

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.