Shanghai SynTheAll Pharmaceutical Co., Ltd. FDA Record
Shanghai SynTheAll Pharmaceutical Co., Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Shanghai SynTheAll Pharmaceutical Co., Ltd." is on file.
- Latest inspection
- Apr 25, 2025 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | Jinshan District, Shaanghai, China | Drugs | Voluntary Action Indicated (VAI) | 3006337946 |
| Jul 19, 2018 | Jinshan District, Shaanghai, China | Drugs | No Action Indicated (NAI) | 3006337946 |
| Apr 8, 2016 | Jinshan District, Shaanghai, China | Drugs | No Action Indicated (NAI) | 3006337946 |
| Jul 17, 2014 | Jinshan District, Shaanghai, China | Drugs | Voluntary Action Indicated (VAI) | 3006337946 |
| Aug 15, 2013 | Jinshan District, Shaanghai, China | Drugs | No Action Indicated (NAI) | 3006337946 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3006337946 | Jinshan District, Shaanghai, China | 5 | Apr 25, 2025 |
Shanghai SynTheAll Pharmaceutical Co., Ltd. and the FDA: common questions
Has Shanghai SynTheAll Pharmaceutical Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Shanghai SynTheAll Pharmaceutical 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 Shanghai SynTheAll Pharmaceutical Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Shanghai SynTheAll Pharmaceutical Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Shanghai SynTheAll Pharmaceutical Co., Ltd.?
The most recent FDA inspection on file ended Apr 25, 2025 at Jinshan District, Shaanghai, China and was classified VAI. FDA has 5 inspections of Shanghai SynTheAll Pharmaceutical Co., Ltd. on file.
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