Warning letter
Polaroisin International Co., Ltd.: warning letter of Jan 25, 2018
FDA warning letter 541792 · Center for Drug Evaluation and Research
Key facts
| Reference number | 541792 |
|---|---|
| Company | Polaroisin International Co., Ltd. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 25, 2018 |
| Posted date | Feb 6, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.66, 211.34, 211.84(d)(1), 211.100(a), 211.165(a), 211.137(a) |
| Inspection city | New Taipei City |
| Inspection start date | Sep 11, 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: