Jiangsu Shenli Medical Production Co., Ltd. FDA Record

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

  • Latest inspection OAI · Mar 29, 2024
  • Last warning letter 2024
Inspections 3 1 OAI
Recalls 87 0 Class I (0%)
Warning letters 2 Latest Jul 18, 2024
510(k) clearances 3 Latest Sep 28, 2020

Jiangsu Shenli Medical Production Co., Ltd. has 87 FDA recalls, 3 inspections, 3 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Jiangsu Shenli Medical Production Co., Ltd., the most recent on Jul 18, 2024.

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

Latest recall
Z-2045-2024 · Class II · Apr 5, 2024
Latest inspection
Mar 29, 2024 · OAI
Latest 510(k)
Sep 28, 2020

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls87Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

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Jiangsu Shenli Medical Production Co., Ltd. FDA Warning Letters

2 warning letters from Mar 18, 2024 to Jul 18, 2024.

IssuedSubjectIssuing officeClose-out letter
Jul 18, 2024 · Letter on fda.gov CGMP/QSR/Medical Devices/AdulteratedCenter for Devices and Radiological Health
Mar 18, 2024 · Letter on fda.gov CGMP/QSR/Medical Devices/PMA/Adulterated/MisbrandedCenter for Devices and Radiological Health

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

87 recall records on Apr 5, 2024. Showing the 20 most recent. View all 87 recall records

NumberClassProductDate
Z-2045-2024Class IIBrand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description…Apr 5, 2024
Z-2100-2024Class IIBrand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number…Apr 5, 2024
Z-2114-2024Class IIBrand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product…Apr 5, 2024
Z-2065-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product…Apr 5, 2024
Z-2058-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product…Apr 5, 2024
Z-2079-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product…Apr 5, 2024
Z-2127-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product…Apr 5, 2024
Z-2069-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product…Apr 5, 2024
Z-2123-2024Class IIBrand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product…Apr 5, 2024
Z-2054-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product…Apr 5, 2024
Z-2087-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product…Apr 5, 2024
Z-2128-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product…Apr 5, 2024
Z-2093-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product…Apr 5, 2024
Z-2110-2024Class IIBrand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product…Apr 5, 2024
Z-2049-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description…Apr 5, 2024
Z-2077-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product…Apr 5, 2024
Z-2073-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product…Apr 5, 2024
Z-2119-2024Class IIBrand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product…Apr 5, 2024
Z-2109-2024Class IIBrand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product…Apr 5, 2024
Z-2056-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product…Apr 5, 2024

Recent FDA inspections

3 inspections from Nov 15, 2012 to Mar 29, 2024.

DateSiteProductClassificationFEI
Mar 29, 2024Changzhou, ChinaDevicesOfficial Action Indicated (OAI)3003902757
May 7, 2015Changzhou, ChinaDevicesNo Action Indicated (NAI)3003902757
Nov 15, 2012Changzhou, ChinaDevicesNo Action Indicated (NAI)3003902757
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.

Compliance Actions

FDA's compliance actions data lists 2 compliance actions under Jiangsu Shenli Medical Production Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 18, 2024.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003902757Changzhou, China3Mar 29, 2024

Recent 510(k) clearances

3 510(k) clearances from Mar 14, 2017 to Sep 28, 2020.

K-NumberDeviceDate
K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)Sep 28, 2020
K180259Sterile Hypodermic Needle for Single UseMay 18, 2018
K163093Safety Blood Collection SetMar 14, 2017

Jiangsu Shenli Medical Production Co., Ltd. and the FDA: common questions

Has Jiangsu Shenli Medical Production Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Jiangsu Shenli Medical Production Co., Ltd.. The most recent is dated Jul 18, 2024, with the subject "CGMP/QSR/Medical Devices/Adulterated".

Has Jiangsu Shenli Medical Production Co., Ltd. received an FDA Form 483?

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

When did the FDA last inspect Jiangsu Shenli Medical Production Co., Ltd.?

The most recent FDA inspection on file ended Mar 29, 2024 at Changzhou, China and was classified OAI. FDA has 3 inspections of Jiangsu Shenli Medical Production Co., Ltd. on file, 1 of them classified OAI (official action indicated).

Has Jiangsu Shenli Medical Production Co., Ltd. had an FDA recall?

Yes. Jiangsu Shenli Medical Production Co., Ltd. has 87 FDA recalls on record. The most recent started Apr 5, 2024.

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