FDA Inspection
Formulated Solutions, LLCFormulated Solutions, LLC – FDA Inspection, Apr 4, 2025
Record Details
This FDA Inspection record concerns Formulated Solutions, LLC, with an inspection on April 4, 2025, issued by the Florida District Office, covering human drugs.
View Company Profile
ID · 483f555b-07e0-42e9-8754-5c59b32916b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250792
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Formulated Solutions, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1101994 - 2019-08-29
- FDA Inspection 1034744 - 2017-12-08
- FDA Inspection 856308 - 2013-11-18
- FDA Inspection 645425 - 2010-02-11
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.