FDA Inspection
Formulated Solutions, LLCFormulated Solutions, LLC – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns Formulated Solutions, LLC, with an inspection on December 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · 992b69c8-1ef5-4132-a4db-cc6a228fb9ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034744
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Formulated Solutions, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| August 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Formulated Solutions, LLC
- FDA Inspection 1250792 - 2025-04-04
- FDA Inspection 1101994 - 2019-08-29
- FDA Inspection 856308 - 2013-11-18
- FDA Inspection 645425 - 2010-02-11
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