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 Alps Pharmaceutical Industrial Co., Ltd. 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 Alps Pharmaceutical Industrial Co., Ltd. had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Alps Pharmaceutical Industrial Co., Ltd. so far. Argus ingests new FDA records daily.

October 17, 2025 FDA Form 483 for Alps Pharmaceutical Industrial Co., Ltd.

Here's the summary: FDA inspected Alps Pharmaceutical Industrial Co., Ltd. in Japan and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2025-10-17. FDA records classify Alps Pharmaceutical Industrial Co., Ltd. as a active pharmaceutical ingredient 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.

Key facts

Firm	Alps Pharmaceutical Industrial Co., Ltd.
FEI / inspection ID	3002806352
Inspection end date	October 17, 2025
Citation count	2

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 — QC laboratory established written procedure for synchronization of laboratory instruments time with

QC laboratory established written procedure for synchronization of laboratory instruments time with the actual time was not followed. For example, QC laboratory SOP: 013-41, Quality Control Procedure, Effective Date: 2025-05-23, Version 41 , states that QC laboratory instruments time shall be synchronized within plus or minus~~ 4 <6>< > 'of the actual time. The hardware time display of the HPLC was not synchronized with the network LabSolution software. On 10/ 16/2025 during the walk through inspection ~f the QC laboratory the hardware time display of #HPLC 100-6-34 displayed the time difference o (b) < > and #HPLC 100-6-40 displayed the time difference of 1 4 (b>< > rom the actual time which did not meet the requirement as per the established written procedure. HPLC 4 #HPLCI00-6-34 is used for release test of 1 < >d ~ I and HPLC #HPLCl00-6-40 is used for release testing of4 ti>>< > PI that are either shippe 'a irectly or indirect to the US.

Observation 2 — Microbiological laboratory lacked established written procedure for cleaning of incubators and labeling

Microbiological laboratory lacked established written procedure for cleaning of incubators and labeling of d. ·(l>m ld prepare me 1a or examp es, A. There is no established written procedure for cleaning of incubators in which incubator Hl 00- inside cabinet seal door was observed containing mold and mildews on 10/15/2025 during the walk through inspection. Incubator #Hl00-25-7 is used to incubate mediaE.:__plates for microbiological testing of finished APis that are shipped to the US. B. There is no established written procedure for proper labeling media (6)(4J plates. The current practice of labeling prepare media'l6><4 > plates does not contain the initial of the analyst, the date of inoculation, and identification of the sample that can be tracked to the analytical worksheet. SEE REVERSE OF THIS PAGE

Alps Pharmaceutical Industrial Co., Ltd.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Alps Pharmaceutical Industrial Co., Ltd.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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 Alps Pharmaceutical Industrial Co., Ltd. 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 Alps Pharmaceutical Industrial Co., Ltd. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Alps Pharmaceutical Industrial Co., Ltd. so far. Argus ingests new FDA records daily.

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Full FDA history for Alps Pharmaceutical Industrial Co., Ltd.

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). October 17, 2025 FDA Form 483 for Alps Pharmaceutical Industrial Co., Ltd. — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-alps-pharmaceutical-industrial-co-ltd-2025-10-17-3002806352

MLA

"October 17, 2025 FDA Form 483 for Alps Pharmaceutical Industrial Co., Ltd. — 2 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-alps-pharmaceutical-industrial-co-ltd-2025-10-17-3002806352.

Chicago

Argus HQ Research. "October 17, 2025 FDA Form 483 for Alps Pharmaceutical Industrial Co., Ltd. — 2 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-alps-pharmaceutical-industrial-co-ltd-2025-10-17-3002806352.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_alps_pharmaceutical_industrial_co_ltd_2025_10_17_3002806352_2025,
  title = {October 17, 2025 FDA Form 483 for Alps Pharmaceutical Industrial Co., Ltd. — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-alps-pharmaceutical-industrial-co-ltd-2025-10-17-3002806352},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗