FDA Inspection
Technological Medical Advancements LLCTechnological Medical Advancements LLC – FDA Inspection, Feb 24, 2020
Record Details
This FDA Inspection record concerns Technological Medical Advancements LLC, with an inspection on February 24, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 24, 2020
- Product Type
- Devices
View Company Profile
ID · 3f795e04-1910-40b3-8439-b44772704d8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1118651
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 1040.11(a)(3)Aperture label
- 21 CFR 1040.10(f)(5)(ii)Emission indicator - Class IIIb & IV
- 21 CFR 1010.2(b)Certification other than by tag or label
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Technological Medical Advancements LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Medical Devices |
| September 9, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Technological Medical Advancements LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.