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Hubei JXBio Pharmaceutical Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Hubei JXBio Pharmaceutical Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hubei JXBio Pharmaceutical Co., Ltd." is on file. FDA has published 1 Form 483 for Hubei JXBio Pharmaceutical Co., Ltd..

What these totals cover: FDA records filed under the name "Hubei JXBio Pharmaceutical Co., Ltd." and its spelling variant "Hubei Jxbio Pharmaceutical Co".

Latest inspection: Mar 14, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hubei JXBio Pharmaceutical Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Hubei JXBio Pharmaceutical Co., Ltd. Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Mar 14, 2025 · Document on fda.gov	483	3016784508

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

2 inspections from Aug 30, 2024 to Mar 14, 2025.

Date	Site	Product	Classification	FEI
Mar 14, 2025	Xianning, China	Drugs	Voluntary Action Indicated (VAI)	3016784508
Aug 30, 2024	Xianning, China	Veterinary	Voluntary Action Indicated (VAI)	3016784508

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3016784508	Xianning, China	2	Mar 14, 2025

Hubei JXBio Pharmaceutical Co., Ltd. and the FDA: common questions

Has Hubei JXBio Pharmaceutical Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Hubei JXBio Pharmaceutical Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Hubei JXBio Pharmaceutical Co., Ltd. received an FDA Form 483?

FDA has published 1 Form 483 for Hubei JXBio Pharmaceutical Co., Ltd. in its reading room, the most recent dated Mar 14, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hubei JXBio Pharmaceutical Co., Ltd.?

The most recent FDA inspection on file ended Mar 14, 2025 at Xianning, China and was classified VAI. FDA has 2 inspections of Hubei JXBio Pharmaceutical Co., Ltd. on file.

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