FDA Inspection
Always More Marketing IncAlways More Marketing Inc – FDA Inspection, Aug 10, 2018
Record Details
This FDA Inspection record concerns Always More Marketing Inc, with an inspection on August 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Mark W. Babbitt (Issuing Officer)
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ID · 91baf14b-f23f-473f-95df-faff6ec8c73c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061750
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 812.18(b)Exporter of investigational device
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)(iii)Investigator records of exposure to device inadequate
- 21 CFR 812.140(a)(2)(ii)Investigator records of persons receiving devices inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.5(a)Label does not contain required information
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
Showing 10 of 11 citations.
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Other FDA inspections of Always More Marketing Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| September 29, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 12, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Always More Marketing Inc
- FDA Inspection 1252743 - 2024-10-17
- FDA Inspection 1154261 - 2021-09-29
- FDA Inspection 996913 - 2016-11-15
- FDA Inspection 848035 - 2013-09-12
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