FDA Inspection 904809 — Alan Neuromedical Technologies
The FDA completed an inspection of Alan Neuromedical Technologies on November 5, 2014 in The Woodlands, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 5, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- The Woodlands, TX (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 2995 | 21 CFR 812.140(b)(4) | Availability of records of non-significant risk studies |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |