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 Hubei JXBio Pharmaceutical 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 Hubei JXBio Pharmaceutical Co., Ltd. had other FDA inspection citations?

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

March 14, 2025 FDA Form 483 for Hubei JXBio Pharmaceutical Co., Ltd.

FDA inspected Hubei JXBio Pharmaceutical Co., Ltd. in China and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-03-14. FDA records classify Hubei JXBio Pharmaceutical Co., Ltd. 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.

Key facts

Firm	Hubei JXBio Pharmaceutical Co., Ltd.
FEI / inspection ID	3016784508
Inspection end date	March 14, 2025
Citation count	1

Citations explained

Observation 1 — Deviations and Out-of-Specifications (OOS) are not clearly documented, explained, or investigated in

Deviations and Out-of-Specifications (OOS) are not clearly documented, explained, or investigated in production discrepancy reports. Specifically, A. An investigation for deviation PC-C005-24002 was initiated on 04-12-2024 for a test result that did not meet requirements for Batch Intermediate purity due to improper use of a balance during material weighing. The CAPA for replacement of all the electronic scales in the workshop with those having a printing function was not implemented using the established change control process. B. An investigation for deviation PC-C005A-24002 was initiated on 04-04-2024 for a single impurity test result that did not meet requirements during the of Batch The deviation was opened following the closing of OOS-C005A-24001 on 04-05-2024 but did not reference the OOS investigation and conclusion. Add Continuation Page SEE REVERSE OF THIS PAGE

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.

Hubei JXBio Pharmaceutical Co., Ltd.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Hubei JXBio Pharmaceutical 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 Hubei JXBio Pharmaceutical 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 Hubei JXBio Pharmaceutical Co., Ltd. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Hubei JXBio Pharmaceutical Co., Ltd. so far. Argus ingests new FDA records daily.

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Full FDA history for Hubei JXBio Pharmaceutical 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). March 14, 2025 FDA Form 483 for Hubei JXBio Pharmaceutical Co., Ltd. — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-hubei-jxbio-pharmaceutical-co-ltd-2025-03-14-3016784508

MLA

"March 14, 2025 FDA Form 483 for Hubei JXBio Pharmaceutical Co., Ltd. — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-hubei-jxbio-pharmaceutical-co-ltd-2025-03-14-3016784508.

Chicago

Argus HQ Research. "March 14, 2025 FDA Form 483 for Hubei JXBio Pharmaceutical Co., Ltd. — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-hubei-jxbio-pharmaceutical-co-ltd-2025-03-14-3016784508.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_hubei_jxbio_pharmaceutical_co_ltd_2025_03_14_3016784508_2025,
  title = {March 14, 2025 FDA Form 483 for Hubei JXBio Pharmaceutical Co., Ltd. — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-hubei-jxbio-pharmaceutical-co-ltd-2025-03-14-3016784508},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗