Biofermin Pharmaceutical Co., Ltd. Kobe Plant FDA Record
Biofermin Pharmaceutical Co., Ltd. Kobe Plant has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Biofermin Pharmaceutical Co., Ltd. Kobe Plant" is on file.
- Latest inspection
- Jan 25, 2019 · NAI
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 | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 25, 2019 | Kobe, Japan | Food/Cosmetics | No Action Indicated (NAI) | 3013222283 |
- 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 3013222283 | Kobe, Japan | 1 | Jan 25, 2019 |
Biofermin Pharmaceutical Co., Ltd. Kobe Plant and the FDA: common questions
Has Biofermin Pharmaceutical Co., Ltd. Kobe Plant received an FDA warning letter?
No FDA warning letter addressed to the name "Biofermin Pharmaceutical Co., Ltd. Kobe Plant" 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 Biofermin Pharmaceutical Co., Ltd. Kobe Plant received an FDA Form 483?
FDA has not published a Form 483 for "Biofermin Pharmaceutical Co., Ltd. Kobe Plant" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Biofermin Pharmaceutical Co., Ltd. Kobe Plant?
The most recent FDA inspection on file ended Jan 25, 2019 at Kobe, Japan and was classified NAI. FDA has 1 inspection of Biofermin Pharmaceutical Co., Ltd. Kobe Plant on file.
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