FDA Inspection 1287776 — Stalk Tech Corp.
The FDA completed an inspection of Stalk Tech Corp. on Oct 20, 2025 in San Antonio, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 20, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5145 | 21 CFR 1040.10(f)(2)(ii) | Safety lock failed to prevent access |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5206 | 21 CFR 1040.10(i) | Certified product modification |
| 5670 | 21 CFR 1040.10(h)(2)(ii) | Reproductions of warnings |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |
| 5818 | 21 CFR 1002.40(a) | Obtaining info on first purchasers |