FDA Inspection
Focus Medical, LLCFocus Medical, LLC – FDA Inspection, Mar 29, 2012
Record Details
This FDA Inspection record concerns Focus Medical, LLC, with an inspection on March 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Focus Medical, LLC
- Inspection Date
- March 29, 2012
- Product Type
- Devices
View Company Profile
ID · 95b424b0-3bf0-4022-9cf0-e5cfeeafd993
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775537
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.11Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Focus Medical, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | OAI | New England District Office | Radiation Control and Health Safety Act (RCHSA) Authority |
| May 23, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 6, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Focus Medical, LLC
- FDA Inspection 1271132 - 2025-05-02
- FDA Inspection 1091843 - 2019-05-23
- FDA Inspection 976150 - 2016-06-29
- FDA Inspection 880771 - 2014-05-28
- FDA Inspection 683899 - 2010-10-06
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