FDA Inspection 1270505 — Baylab USA, LLC
The FDA completed an inspection of Baylab USA, LLC on May 20, 2025 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 20, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |