Jiangsu Shenli Medical Production Co., Ltd. FDA Record
- Latest inspection OAI · Mar 29, 2024
- Last warning letter 2024
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.
- Latest recall
- Z-2045-2024 · Class II · Apr 5, 2024
- Latest inspection
- Mar 29, 2024 · OAI
- Latest 510(k)
- Sep 28, 2020
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 87 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Jiangsu Shenli Medical Production Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jul 18, 2024 · Letter on fda.gov | CGMP/QSR/Medical Devices/Adulterated | Center for Devices and Radiological Health | |
| Mar 18, 2024 · Letter on fda.gov | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | Center for Devices and Radiological Health |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2045-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description… | Apr 5, 2024 |
| Z-2100-2024 | Class II | Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number… | Apr 5, 2024 |
| Z-2114-2024 | Class II | Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product… | Apr 5, 2024 |
| Z-2065-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product… | Apr 5, 2024 |
| Z-2058-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product… | Apr 5, 2024 |
| Z-2079-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product… | Apr 5, 2024 |
| Z-2127-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product… | Apr 5, 2024 |
| Z-2069-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product… | Apr 5, 2024 |
| Z-2123-2024 | Class II | Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product… | Apr 5, 2024 |
| Z-2054-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product… | Apr 5, 2024 |
| Z-2087-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product… | Apr 5, 2024 |
| Z-2128-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product… | Apr 5, 2024 |
| Z-2093-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product… | Apr 5, 2024 |
| Z-2110-2024 | Class II | Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product… | Apr 5, 2024 |
| Z-2049-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description… | Apr 5, 2024 |
| Z-2077-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product… | Apr 5, 2024 |
| Z-2073-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product… | Apr 5, 2024 |
| Z-2119-2024 | Class II | Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product… | Apr 5, 2024 |
| Z-2109-2024 | Class II | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product… | Apr 5, 2024 |
| Z-2056-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product… | Apr 5, 2024 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 29, 2024 | Changzhou, China | Devices | Official Action Indicated (OAI) | 3003902757 |
| May 7, 2015 | Changzhou, China | Devices | No Action Indicated (NAI) | 3003902757 |
| Nov 15, 2012 | Changzhou, China | Devices | No 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.
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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003902757 | Changzhou, China | 3 | Mar 29, 2024 |
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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