Warning letter
Haw Par Healthcare Limited: warning letter of Aug 19, 2019
FDA warning letter 578581 · Center for Drug Evaluation and Research
Key facts
| Reference number | 578581 |
|---|---|
| Company | Haw Par Healthcare Limited |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Aug 19, 2019 |
| Posted date | Sep 3, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.303, 201.128, 211.34, 211.63, 211.192, 201.303(b), 211.160(b), 211.194(a) |
| Inspection city | Singapore |
| Inspection start date | Feb 25, 2019 |
| 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: