Catalent CTS, LLC

FDA Regulatory Profile

Catalent CTS, LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 4, 2022 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections8Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Catalent Pharma Solutions
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Catalent Germany Eberbach
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Catalent Germany Schorndorf
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Catalent Micron Technologies
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Catalent France Beinheim
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Catalent Maryland
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Catalent Micron Technologies, Limited
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Catalent Massachusetts
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0030—

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 4, 2022Kansas City, MODrugsNo Action Indicated (NAI)3002929455
Nov 6, 2017Kansas City, MOVeterinaryNo Action Indicated (NAI)3002929455
Jun 29, 2015Kansas City, MOVeterinaryNo Action Indicated (NAI)3002929455
Nov 10, 2014Kansas City, MODrugsVoluntary Action Indicated (VAI)3002929455
Mar 5, 2014Kansas City, MODrugsNo Action Indicated (NAI)3002929455
Jan 14, 2013Kansas City, MODrugsNo Action Indicated (NAI)3002929455
Jun 8, 2012Kansas City, MODrugsNo Action Indicated (NAI)3002929455
Mar 24, 2010Kansas City, MOVeterinaryNo Action Indicated (NAI)3002929455

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002929455Kansas City, MO8Mar 4, 2022

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