FDA Inspection
The Helping Hand Company Alliance LLCThe Helping Hand Company Alliance LLC – FDA Inspection, Aug 31, 2016
Record Details
This FDA Inspection record concerns The Helping Hand Company Alliance LLC, with an inspection on August 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 31, 2016
- Product Type
- Devices
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ID · f436ae3c-b331-45f0-b5d5-4a72764594ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982279
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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