Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) FDA Record
Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)" is on file.
- Latest inspection
- Jan 14, 2025 · VAI
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 | 6 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 14, 2025 | Jinan, China | Drugs | Voluntary Action Indicated (VAI) | 3003802432 |
| Sep 27, 2019 | Jinan, China | Drugs | No Action Indicated (NAI) | 3003802432 |
| Apr 17, 2018 | Jinan, China | Drugs | Voluntary Action Indicated (VAI) | 3003802432 |
| Sep 20, 2017 | Jinan, China | Drugs | Voluntary Action Indicated (VAI) | 3003802432 |
| May 19, 2015 | Jinan, China | Drugs | Voluntary Action Indicated (VAI) | 3003802432 |
| Jul 18, 2013 | Jinan, China | Drugs | Voluntary Action Indicated (VAI) | 3003802432 |
- 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 3003802432 | Jinan, China | 6 | Jan 14, 2025 |
Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) and the FDA: common questions
Has Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) received an FDA warning letter?
No FDA warning letter addressed to the name "Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)" 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 Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) received an FDA Form 483?
FDA has not published a Form 483 for "Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)?
The most recent FDA inspection on file ended Jan 14, 2025 at Jinan, China and was classified VAI. FDA has 6 inspections of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) on file.
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