Tianjin Rilifine Medical Device Co., Ltd. FDA Record

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

  • Latest inspection VAI · Jul 31, 2025
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 2 Latest Nov 21, 2022

Tianjin Rilifine Medical Device Co., Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Tianjin Rilifine Medical Device Co., Ltd." is on file.

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

Latest inspection
Jul 31, 2025 · VAI
Latest 510(k)
Nov 21, 2022

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 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 Jul 31, 2025.

DateSiteProductClassificationFEI
Jul 31, 2025Tianjin, ChinaDevicesVoluntary Action Indicated (VAI)3021314645
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 3021314645Tianjin, China1Jul 31, 2025

Recent 510(k) clearances

2 510(k) clearances from Nov 15, 2022 to Nov 21, 2022.

K-NumberDeviceDate
K222246Disposable Sterile LancetNov 21, 2022
K222055Disposable Sterile LancetNov 15, 2022

Tianjin Rilifine Medical Device Co., Ltd. and the FDA: common questions

Has Tianjin Rilifine Medical Device Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Tianjin Rilifine Medical Device 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 Tianjin Rilifine Medical Device Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Tianjin Rilifine Medical Device Co., Ltd.?

The most recent FDA inspection on file ended Jul 31, 2025 at Tianjin, China and was classified VAI. FDA has 1 inspection of Tianjin Rilifine Medical Device Co., Ltd. on file.

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