Changzhou SynTheAll Pharmaceutical Co., Ltd FDA Record
Changzhou SynTheAll Pharmaceutical Co., Ltd has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Changzhou SynTheAll Pharmaceutical Co., Ltd" is on file.
- Latest inspection
- Mar 7, 2025 · NAI
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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 | 2 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 7, 2025 | Changzhou, China | Drugs | No Action Indicated (NAI) | 3012897823 |
| Jul 19, 2019 | Changzhou, China | Drugs | No Action Indicated (NAI) | 3012897823 |
- 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 3012897823 | Changzhou, China | 2 | Mar 7, 2025 |
Changzhou SynTheAll Pharmaceutical Co., Ltd and the FDA: common questions
Has Changzhou SynTheAll Pharmaceutical Co., Ltd received an FDA warning letter?
No FDA warning letter addressed to the name "Changzhou 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 Changzhou SynTheAll Pharmaceutical Co., Ltd received an FDA Form 483?
FDA has not published a Form 483 for "Changzhou SynTheAll Pharmaceutical Co., Ltd" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Changzhou SynTheAll Pharmaceutical Co., Ltd?
The most recent FDA inspection on file ended Mar 7, 2025 at Changzhou, China and was classified NAI. FDA has 2 inspections of Changzhou SynTheAll Pharmaceutical Co., Ltd on file.
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