FDA Inspection 1061750 — Always More Marketing Inc
The FDA completed an inspection of Always More Marketing Inc on August 10, 2018 in Calabasas, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Calabasas, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2920 | 21 CFR 812.18(b) | Exporter of investigational device |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |
| 2982 | 21 CFR 812.140(a)(2)(ii) | Investigator records of persons receiving devices inadequate |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 3063 | 21 CFR 812.140(a)(3)(iii) | Investigator records of exposure to device inadequate |
| 6849 | 21 CFR 812.5(a) | Label does not contain required information |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7378 | 21 CFR 50.27(a) | Copy of consent form not provided |