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.

What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

Does this Form 483 mean Ajinomoto Company Inc. 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.

February 21, 2025 FDA Form 483 for Ajinomoto Company Inc.

Key facts

Firm	Ajinomoto Company Inc.
FEI / inspection ID	3002806336
Inspection end date	February 21, 2025
Citation count	1

Key takeaway: FDA inspected Ajinomoto Company Inc. in Japan and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-02-21. FDA records classify Ajinomoto Company Inc. as a api (animal origin) manufacturer. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Citations explained

Observation 1 — DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 02/17-21/2025 12420 Parklawn Drive, Room 2032 Rockville, MD 20857 FEI NUMBER 3002806336 Industry Information: www.fda.gov/oc/industry AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO Akiko Sumikawa. General Manager FIRM NAME STREET ADDRESS Ajinomoto Company Inc. Kawasaki Plant. 1-1 Suzuki -Cho. Kawasaki -Ku "CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED Kawasaki -City. Kanagawa, 210-8680. Japan API Manufacturer THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE OBJECTION OR ACTION WITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF YOU HAVE ANY QUESTIONS, PLEASE.

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.

Ajinomoto Company Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Ajinomoto Company Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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.
What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
Does this Form 483 mean Ajinomoto Company Inc. 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.

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Full FDA history for Ajinomoto Company 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.

APA

Argus HQ Research (2025). February 21, 2025 FDA Form 483 for Ajinomoto Company Inc. — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-ajinomoto-company-inc-2025-02-21-3002806336

MLA

"February 21, 2025 FDA Form 483 for Ajinomoto Company Inc. — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-ajinomoto-company-inc-2025-02-21-3002806336.

Chicago

Argus HQ Research. "February 21, 2025 FDA Form 483 for Ajinomoto Company Inc. — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-ajinomoto-company-inc-2025-02-21-3002806336.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_ajinomoto_company_inc_2025_02_21_3002806336_2025,
  title = {February 21, 2025 FDA Form 483 for Ajinomoto Company Inc. — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-ajinomoto-company-inc-2025-02-21-3002806336},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗