Warning letter
Taiwan Biotech Co., LTD.: warning letter of May 31, 2018
FDA warning letter UCM609829 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM609829 |
|---|---|
| Company | Taiwan Biotech Co., LTD. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 31, 2018 |
| Posted date | May 31, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Devices |
| CFR sections cited | 211.34, 211.42(c)(10)(iv), 211.166(a), 211.180(e) |
| Country | 3 |
| Inspection city | Taoyuan City |
| Inspection start date | Sep 1, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: