FDA Inspection
Healing Solutions LLCHealing Solutions LLC – FDA Inspection, May 3, 2012
Record Details
This FDA Inspection record concerns Healing Solutions LLC, with an inspection on May 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Healing Solutions LLC
- Inspection Date
- May 3, 2012
- Product Type
- Devices
View Company Profile
ID · 12493c9f-4296-44ec-ba67-72984d74840f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 779597
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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