FDA Inspection
GTG WELLNESS CO LTDGTG WELLNESS CO LTD – FDA Inspection, Mar 23, 2023
Record Details
This FDA Inspection record concerns GTG WELLNESS CO LTD, with an inspection on March 23, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b5beb151-dd11-491d-bb9e-3b4a801fc9dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1202195
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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