Warning letter
Indus Medicare Limited: warning letter of May 4, 2020
FDA warning letter 606159 · Center for Devices and Radiological Health
Key facts
| Reference number | 606159 |
|---|---|
| Company | Indus Medicare Limited |
| Subject | Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded |
| Issue date | May 4, 2020 |
| Posted date | May 12, 2020 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 820, 803.50(a) |
| Inspection city | Medak District |
| Inspection start date | Jan 20, 2020 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: