FDA Inspection 1271850 — Transdermal Cap Inc.
The FDA completed an inspection of Transdermal Cap Inc. on June 6, 2025 in Highland Heights, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Highland Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |