FDA Inspection
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Tangible Solutions, Inc. DBA Marle Tangible, Inc. – FDA Inspection, Oct 5, 2022
Record Details
This FDA Inspection record concerns Tangible Solutions, Inc. DBA Marle Tangible, Inc., with an inspection on October 5, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 5, 2022
- Product Type
- Devices
View Company Profile
ID · 11e19672-deff-4156-83e2-6cab7b20f7fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tangible Solutions, Inc. DBA Marle Tangible, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tangible Solutions, Inc. DBA Marle Tangible, Inc.
- FDA Inspection 1254743 - 2024-11-05
- FDA Inspection 1081752 - 2018-12-06
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