FDA Inspection 1323752 — ALIEN MILLING TECHNOLOGIES
The FDA completed an inspection of ALIEN MILLING TECHNOLOGIES on June 25, 2026 in Glendora, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glendora, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23049 | ISO 13485:2016 Clause 5.1 | Lack of evidence for top management's commitment to QMS |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23238 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not adequately evaluated |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |