Warning letter
Bioptimal International: warning letter of Apr 3, 2024
FDA warning letter 678281 · "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality"
Key facts
| Reference number | 678281 |
|---|---|
| Company | Bioptimal International |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 3, 2024 |
| Posted date | May 7, 2024 |
| Issuing office | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" |
| Product type | Devices |
| CFR sections cited | 803.18(b)(1)(i), 803.50(a)(1), 803.50(a), 820, 807.81(a)(3)(i), 807.81(b), 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(3), 803.17(b) and 1 more |
| Inspection city | Singapore |
| Inspection start date | Nov 6, 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: