Bq Plus Medical Co., Ltd. FDA Record

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

Bq Plus Medical Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bq Plus Medical Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Bq Plus Medical Co., Ltd." and its spelling variant "Bq Plus Medical Co".

Latest inspection
Mar 26, 2025 · NAI
Latest 510(k)
Aug 22, 2024

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Mar 26, 2025.

DateSiteProductClassificationFEI
Mar 26, 2025Shanghai, ChinaDevicesNo Action Indicated (NAI)3013023255
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.

FacilityLocationInspectionsLatest
FEI 3013023255Shanghai, China1Mar 26, 2025

Recent 510(k) clearances

3 510(k) clearances from Aug 14, 2021 to Aug 22, 2024.

K-NumberDeviceDate
K242126I.V. Administration SetAug 22, 2024
K223645I.V. Administration Set, I.V. Extension SetMay 18, 2023
K210381I.V. Administration SetAug 14, 2021

Bq Plus Medical Co., Ltd. and the FDA: common questions

Has Bq Plus Medical Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Bq Plus Medical 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 Bq Plus Medical Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Bq Plus Medical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Bq Plus Medical Co., Ltd.?

The most recent FDA inspection on file ended Mar 26, 2025 at Shanghai, China and was classified NAI. FDA has 1 inspection of Bq Plus Medical Co., Ltd. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.