FDA Inspection 1314406 — APMTD, INC.
The FDA completed an inspection of APMTD, INC. on April 28, 2026 in Wilmington, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wilmington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23169 | ISO 13485:2016 Clause 7.5.6 | Procedures for validation of processes not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |