FDA Inspection
Method Therapeutic SolutionsMethod Therapeutic Solutions – FDA Inspection, Oct 28, 2015
Record Details
This FDA Inspection record concerns Method Therapeutic Solutions, with an inspection on October 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Method Therapeutic Solutions
- Inspection Date
- October 28, 2015
- Product Type
- Devices
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ID · b1e5299e-9971-4ff2-8414-ea18979d0e52
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 951528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 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 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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