Warning letter
Haw Par Healthcare Limited [ARCHIVED]: warning letter of Jul 20, 2010
FDA warning letter 116848 · Center for Drug Evaluation and Research
Key facts
| Reference number | 116848 |
|---|---|
| Company | Haw Par Healthcare Limited [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated/Misbranded |
| Issue date | Jul 20, 2010 |
| Posted date | Jul 20, 2010 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 166, 211.192, 211.25(a), 211.80(a), 211.84(d)(2), 211.100(b), 211.160(b), 310.3(h)(5), 211.194(a), 211.84(b) |
| Inspection city | Singapore |
| Inspection start date | Oct 26, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: