Key facts
| Firm | Fujifilm Diosynth Biotechnologies USA Inc. |
|---|---|
| FEI / inspection ID | 3000718852 |
| Inspection end date | March 27, 2026 |
| Citation count | 1 |
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 — -- 1 of 5 -- -- 2 of 5 -- -- 3
-- 1 of 5 -- -- 2 of 5 -- -- 3 of 5 -- -- 4 of 5 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration. Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: "Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid,.
Fujifilm Diosynth Biotechnologies USA Inc.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Fujifilm Diosynth Biotechnologies USA Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Fujifilm Diosynth Biotechnologies USA Inc. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Fujifilm Diosynth Biotechnologies USA Inc. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3000718852.
- 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.
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Related enforcement actions
Full FDA history for Fujifilm Diosynth Biotechnologies USA Inc.Compiled 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 (2026). March 27, 2026 FDA Form 483 for Fujifilm Diosynth Biotechnologies USA Inc. — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-usa-inc-2026-03-27-3000718852
"March 27, 2026 FDA Form 483 for Fujifilm Diosynth Biotechnologies USA Inc. — 1 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-usa-inc-2026-03-27-3000718852.
Argus HQ Research. "March 27, 2026 FDA Form 483 for Fujifilm Diosynth Biotechnologies USA Inc. — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-usa-inc-2026-03-27-3000718852.
@misc{argushq_argushq_ai_483_fda_483_fujifilm_diosynth_biotechnologies_usa_inc_2026_03_27_3000718852_2026,
title = {March 27, 2026 FDA Form 483 for Fujifilm Diosynth Biotechnologies USA Inc. — 1 Citations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-fujifilm-diosynth-biotechnologies-usa-inc-2026-03-27-3000718852},
note = {Accessed: July 13, 2026}
}