FDA Inspection
Technological Medical Advancements LLCTechnological Medical Advancements LLC – FDA Inspection, Apr 21, 2025
Record Details
This FDA Inspection record concerns Technological Medical Advancements LLC, with an inspection on April 21, 2025, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
- Inspection Date
- April 21, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8f40c636-8ff6-4d6e-8aee-aff39c232583
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1267219
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
9- 21 CFR 820.198(a)Complaints
- 21 CFR 1040.10(h)(1)(iii)Legible reproductions
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Technological Medical Advancements LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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