Warning letter
Baylab USA, LLC: warning letter of Jun 27, 2024
FDA warning letter 679001 · OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
Key facts
| Reference number | 679001 |
|---|---|
| Company | Baylab USA, LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Jun 27, 2024 |
| Posted date | Aug 13, 2024 |
| Issuing office | OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality |
| Product type | Devices |
| CFR sections cited | 801, 801.3, 803, 803.17, 830, 830.3, 807.81, 801.40(a)(1), 801.40(a)(2), 807.81(a)(3)(i), 878.4040, 801.20(a) and 3 more |
| Inspection city | Dallas |
| Inspection ZIP | 75234 |
| Inspection start date | Jan 24, 2024 |
| 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: