Pou YU Biotechnology Co., Ltd. FDA Record
- Latest inspection VAI · Feb 13, 2014
- No warning letters matched by name
Pou YU Biotechnology Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pou YU Biotechnology Co., Ltd." is on file.
- Latest inspection
- Feb 13, 2014 · VAI
- Latest 510(k)
- Mar 31, 2011
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 6 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 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 |
|---|---|---|---|---|
| Feb 13, 2014 | Changhua County, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3006555015 |
- 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 3006555015 | Changhua County, Taiwan | 1 | Feb 13, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K103339 | TDS ABUTMENT FOR FRIADENT XIVE | Mar 31, 2011 |
| K100356 | TDS PRECISION DENTAL BAR | Oct 5, 2010 |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | Jun 24, 2009 |
| K081460 | TDS ABUTMENT | Nov 21, 2008 |
Pou YU Biotechnology Co., Ltd. and the FDA: common questions
Has Pou YU Biotechnology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Pou YU Biotechnology 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 Pou YU Biotechnology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Pou YU Biotechnology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pou YU Biotechnology Co., Ltd.?
The most recent FDA inspection on file ended Feb 13, 2014 at Changhua County, Taiwan and was classified VAI. FDA has 1 inspection of Pou YU Biotechnology Co., Ltd. on file.
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