Key facts
| Firm | Sanofi-Aventis Deutschland GmbH |
|---|---|
| FEI / inspection ID | 3003195501 |
| Inspection end date | January 16, 2025 |
| Citation count | 4 |
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.
Citations explained
Observation 1 — (bTC4l 0 Procedures designed to prevent microbiological contamination of products purpo1i ing
(bTC4l 0 Procedures designed to prevent microbiological contamination of products purpo1i ing to be sterile are not established and fo llowed.------ A. Environmental monitoring of critical surfaces following ase tic fi llin operations are de fi cien t. I. Microbiological surface sampling of the product contact [ (bHj filling lines in buildin 11. Micro6'iolog1cal surface sam Im~ of secon da1y product contact paiis includin the contact paits and open (b 1141 contact Taii s ai·e not perfo 1med after • (b) C4l • (bT (b)l4l fi 11 ' l'campaign or ,,__ __. campaign on ___.,. or 1 mg mes. 1 B. Inadequate aseptic processin~ ~hnique was observed during the. activities{ erfo 1~ ed in (bTCl • B ·1d· (b>l4~ d • (b)C4l d fill' • N ·1 (b)C4l 1 m m mg J u nn~ setup an 1 m o erat10ns. _ on-sten g oves were used to handle tlie Cb 4 and (bH4l tubing and the (b)C4l during theu.
Observation 2 — Cbn4 DS manufacturing area is not under control to assure product quality
Cbn4 DS manufacturing area is not under control to assure product quality. manu facturing process from CbT (S ~ CbT- ---£--d- . ____f_h_ CbH4 B ·1d· CbH4l h . _____ tep, are per 01m e m an area o t e _____ m mg ___ t at 1s classified as zone CbH4 The area is equipp ed with only basic temperature controls and lacks systems for pressure and humidilty control and enviro nmental monitoring.
Observation 3 — (b)"l4) 01 (b)14~ n • · c (br(4 (bH4 n ot ~
(b)"l4) 01 (b)14~ n • · c (br(4 (bH4 n ot ~ u sed for (b)(4 (bY{4 ---. storage, ___ and CbH of all Cb> <4> during DS manufactu nng process. Although Step CbT {6,(l Use of Cb><4 step (Ste CbH4- do_e_s_n_o_t_a_s_sl-u-·e_p_1_·0_d_u-ct...quality £...o_r_a_n __ _ Cb><4 generation process is less stringent than the (bY{-4 generation.
Observation 4 — There is a lack of assurance that the cleaning procedures used for
There is a lack of assurance that the cleaning procedures used for product-contact process equipment for 1141DP an4 the manufacture of (b CbT, DS and DP are effective in preventing product can yove r and cross-contamination. A. Swab sampling is not perfo1med during cleaning validation of multi-product use iff4 CbT<4l or dedicat ed CbT<4l during DP manu facturing. ------ B. The swab sampling is not perfo 1med during cleaning validation of Cb)l4l DS downstream manu facturing vessel s.
Sanofi-Aventis Deutschland GmbH’s FDA history
Argus HQ has recorded 1 total FDA action tied to Sanofi-Aventis Deutschland GmbH: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Sanofi-Aventis Deutschland GmbH had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Sanofi-Aventis Deutschland GmbH so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3003195501.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Sanofi-Aventis Deutschland GmbHCompiled 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 (2025). January 16, 2025 FDA Form 483 for Sanofi-Aventis Deutschland GmbH — 4 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-sanofi-aventis-deutschland-gmbh-2025-01-16-3003195501
"January 16, 2025 FDA Form 483 for Sanofi-Aventis Deutschland GmbH — 4 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-sanofi-aventis-deutschland-gmbh-2025-01-16-3003195501.
Argus HQ Research. "January 16, 2025 FDA Form 483 for Sanofi-Aventis Deutschland GmbH — 4 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-sanofi-aventis-deutschland-gmbh-2025-01-16-3003195501.
@misc{argushq_argushq_ai_483_fda_483_sanofi_aventis_deutschland_gmbh_2025_01_16_3003195501_2025,
title = {January 16, 2025 FDA Form 483 for Sanofi-Aventis Deutschland GmbH — 4 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-sanofi-aventis-deutschland-gmbh-2025-01-16-3003195501},
note = {Accessed: July 13, 2026}
}