Key facts
| Firm | Janssen Vaccines Corporation |
|---|---|
| FEI / inspection ID | 3012637764 |
| Inspection end date | November 19, 2024 |
| Citation count | 4 |
Citations explained
Observation 1 — Responsibilities and procedures for quality units ai·e not in writing and/or fo
Responsibilities and procedures for quality units ai·e not in writing and/or fo llowed to ens ure the FARS (BPDR) are submitted fo r the distributed products that ai·e implicated with product quality issues. Specifically, You failed to fo llow your procedure, TV- WI-21853 Version 29.0 Product Quality Complaint Investigation (E ffective date 5/ 25 /2024) Section 7 .11 .1.2 that sets the requirement fo r FAR (BPDR) as, " ***Two or more complaints with the same confnmed de fe ct with same root cause for the same finished good lot or a root cause related to a co mmon component lot in more than one finished good lot, with or without signal***" . Your procedure, TV-SOP-31402 Version 6. 0 Adviso1y Notices, US FDA Fo1m 39 11 (Dmg N otification and Health Authority (HA) Communication - Reportable Events Procedure (Effective date 7/1712 024) sets the timeline fo r repo1i ing BPDR as, "***as soon as possible, but no more than I.
Observation 2 — Procedure designed to prevent microbiological contamination of di11g products pmpo1i ing to
Procedure designed to prevent microbiological contamination of di11g products pmpo1i ing to be sterile are not establish ed or fo llowed. A. On 11/13/2024i your vial filling operation recorded multi~le inte rventions during the filling of (bY{4 In' • (bT(4f ~T mL • 1 B h N (bT(4l D • h fi11 · h • 1Jecbo~ ~ via ate o. __ _,_... urmg t e 1 mg, t e via s - o-t -stu --,ck,-s1,.. ·m- l--,il,...taneously in IPC (bY{-4 stoppering stations, and the vial (bTC4l WCl The interventions took (bH4l that necessitated rnnning IPC before the line was ""re- s""'ta- 1""'i-e -.-. .... SEE REVERSE OF THIS PAGE EMPtOYEE(S} SIGNATURE EMPI.OYEE(S) NAME AND TITLE (Print or Type) RaJ· iv R. Di?.itally s!gned by RaJ1v R. Sri vastava - Srivastava - s Raj i v R Sr i vastava, cso Date: 2024.11.19 S 14:27:00 +09'00' DATE ISSU ED 11/1 9/2024
Observation 3 — Aseptic processing areas ai·e deficient r egai·ding systems fo r maintaining any
Aseptic processing areas ai·e deficient r egai·ding systems fo r maintaining any equipment used to control the aseptic conditions. Specifically, A. Aseptic filling processing of finished diu g produ ct i.e. fr om, (bY{-4j vials to aseptic filling and to glass vial sealing processing steps, are per fo 1med within a Gra de A (ISO 5) environmen t. The fo llowing observation was made regard ing your non-viable paiiicle (NVP) monitoring: You manufacture B. Your procedure, TV -SOP-40940 Version 18.0 Validation of Unidirectional Airflow (Laminai-) Device (E ffective date 11 /6/2024) Section 5.3.7.5.1 specifies the acceptance criteria fo r smoke study as, "***Airflow should be linear and uni fo1m without turbulence, eddies, or reflux in both At rest (static conditions) and In operation (dynamic condition) status. SEE REVERSE OF THIS PAGE EMPtOYEE(S} SIGNATURE EMPI.OYEE(S) NAME AND TITLE (Print or Type) Di gita ll y signed Rajiv R. by Raj iv R. - Srivastava -S Srivastava Raj i v R Sr.
Observation 4 — Equipment used in the manufact ure, processing, packing, or holding of diu
Equipment used in the manufact ure, processing, packing, or holding of diu g products is n ot of appropriate d es ign to fa cilitate operations fo r its intended use. Specifically, iff4 Tc 4 Your fnm '~k integrity test WCl machines ai·e n ot adequately qualified such that the Cb C4l , and operating ranges Cb)l4l associated with your diug products --- ------ manufacturing ai·e n ot adequately qualified. You caITi ed out Operation Qualification in two paits; Paits 1 and 2. The OQ Pait 1 is general fun ctional testing of critical parameters, e.g., data entiy, eITor messa es test on accurac of pass/fail analysis, and nmning tests fo r test functions such as CbH 4 The Pait 2 test is designed to verify the functionality of the instiumen t. You did n ot cai1y out 0 2 Pait 1 test fo r youf CbH 4j machines on site and used the vendor provided data (from a d.
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Janssen Vaccines Corporation’s FDA history
Argus HQ has recorded 1 total FDA action tied to Janssen Vaccines Corporation: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Janssen Vaccines Corporation violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Janssen Vaccines Corporation had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Janssen Vaccines Corporation so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3012637764.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Janssen Vaccines CorporationCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). Form 483 Record: Janssen Vaccines Corporation, November 19, 2024 — 4 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-janssen-vaccines-corporation-2024-11-19-3012637764
"Form 483 Record: Janssen Vaccines Corporation, November 19, 2024 — 4 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-janssen-vaccines-corporation-2024-11-19-3012637764.
Argus HQ Research. "Form 483 Record: Janssen Vaccines Corporation, November 19, 2024 — 4 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-janssen-vaccines-corporation-2024-11-19-3012637764.
@misc{argushq_argushq_ai_483_fda_483_janssen_vaccines_corporation_2024_11_19_3012637764_2024,
title = {Form 483 Record: Janssen Vaccines Corporation, November 19, 2024 — 4 Citations},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-janssen-vaccines-corporation-2024-11-19-3012637764},
note = {Accessed: July 13, 2026}
}