Catalent Massachusetts, LLC

FDA Regulatory Profile

Catalent Massachusetts, LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 7, 2026 · VAI

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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
Inspections3Nov 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 Greenville
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Catalent Ontario Limited
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00110—
Catalent Anagni
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Catalent Cts
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Catalent Germany Eberbach
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0070—
Catalent Germany Schorndorf
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0070—
Catalent Micron Technologies
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Catalent France Beinheim
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0060—
Catalent Maryland
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Catalent Micron Technologies, Limited
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0060—

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 7, 2026Chelsea, MADrugsVoluntary Action Indicated (VAI)3011696115
Nov 30, 2021Chelsea, MADrugsVoluntary Action Indicated (VAI)3011696115
Jun 18, 2018Chelsea, MADevicesNo Action Indicated (NAI)3011696115

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 3011696115Chelsea, MA3Apr 7, 2026

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