Janssen Pharmaceutica, Inc.

FDA Regulatory Profile

Janssen Pharmaceutica, Inc. has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 7, 2025 · VAI
Latest 510(k)
Aug 30, 2017

Newer recall under related name Johnson And Johnson Surgical Vision: Jul 31, 2026, Z-3064-2026.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Johnson And Johnson Surgical Vision
Same company group
18490Jul 31, 2026 (Z-3064-2026)
Synthes (Usa) Products
Same company group
1644570Feb 25, 2026 (Z-1703-2026)
Cerenovus
Same company group
110110Oct 2, 2025 (Z-0434-2026)
Ethicon Endo-Surgery
Same company group
5418480Sep 11, 2025 (Z-0147-2026)
Ethicon
Same company group
76208150Aug 15, 2025 (Z-2605-2025)
Johnson And Johnson Vision Care
Same company group
101230Jun 12, 2025 (Z-2163-2025)
Ethicon Endo Surgery
Same company group
4220Mar 7, 2025 (Z-1516-2025)
Biosense Webster
Same company group
337670Jan 5, 2025 (Z-1205-2025)
Ethicon Sarl, A Johnson And Johnson
Same company group
2020Jun 11, 2024 (Z-2407-2024)
Depuy Orthopaedics
Same company group
155210112Mar 12, 2024 (Z-1456-2024)
Depuy Spine
Same company group
367190May 20, 2022 (Z-1324-2022)
Janssen Pharmaceuticals
Same company group
40312Oct 23, 2018 (D-0218-2019)

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 7, 2025Olen, BelgiumDrugsVoluntary Action Indicated (VAI)3002807334
Feb 3, 2021Olen, BelgiumDrugsVoluntary Action Indicated (VAI)3002807334
May 16, 2014Olen, BelgiumDrugsVoluntary Action Indicated (VAI)3002807334
May 10, 2012Olen, BelgiumDrugsNo Action Indicated (NAI)3002807334
Jun 8, 2009Olen, BelgiumDrugsNo Action Indicated (NAI)3002807334

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K163628Idylla Respiratory (IFV-RSV) PanelAug 30, 2017
K850792ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMPNov 13, 1985