Warning letter
P.T. Sankei Medical Industries: warning letter of Sep 19, 2023
FDA warning letter 665754 · Center for Devices and Radiological Health
Key facts
| Reference number | 665754 |
|---|---|
| Company | P.T. Sankei Medical Industries |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 19, 2023 |
| Posted date | Apr 30, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b), 803, 803.3, 803.17, 803.12(a), 803.17(a)(1), 803.17(a)(2), 803.17(b), 807.81(a)(3)(i), 820, 803.50(a) |
| Inspection city | Serang |
| Inspection start date | May 8, 2023 |
| Letter on fda.gov | fda.gov |
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: