Shandong Lianfa Medical Plastic Products Co. , Ltd. FDA Record

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

  • Latest inspection VAI · Jul 24, 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 30, 2022

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

What these totals cover: FDA records filed under the name "Shandong Lianfa Medical Plastic Products Co. , Ltd." and its spelling variants "Shandong Lianfa Medical Plastic Products Co.", "Shandong Lianfa Medical Plastic Products Co".

Latest inspection
Jul 24, 2025 · VAI
Latest 510(k)
Nov 30, 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 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Jul 24, 2025.

DateSiteProductClassificationFEI
Jul 24, 2025Jinan, ChinaDevicesVoluntary Action Indicated (VAI)3008801456
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 3008801456Jinan, China1Jul 24, 2025

Recent 510(k) clearances

2 510(k) clearances from Oct 3, 2022 to Nov 30, 2022.

K-NumberDeviceDate
K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceNov 30, 2022
K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Oct 3, 2022

Shandong Lianfa Medical Plastic Products Co. , Ltd. and the FDA: common questions

Has Shandong Lianfa Medical Plastic Products Co. , Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Shandong Lianfa Medical Plastic Products 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 Shandong Lianfa Medical Plastic Products Co. , Ltd. received an FDA Form 483?

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

When did the FDA last inspect Shandong Lianfa Medical Plastic Products Co. , Ltd.?

The most recent FDA inspection on file ended Jul 24, 2025 at Jinan, China and was classified VAI. FDA has 1 inspection of Shandong Lianfa Medical Plastic Products Co. , Ltd. on file.

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