FDA Inspection
Sincerus Florida, LLC dba SKNVSincerus Florida, LLC dba SKNV – FDA Inspection, May 23, 2024
Record Details
This FDA Inspection record concerns Sincerus Florida, LLC dba SKNV, with an inspection on May 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7a062c2f-f554-4f50-b47d-232f4f863128
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229212
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- Drug product container, fails to include
- Outsourcing facility, compounded drug report follow up
- FDCA 503B(a)(10)(B)Drug product container, fails to include
- FDCA 503B(b)(2)(A)Outsourcing facility, compounded drug report follow up
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Other FDA inspections of Sincerus Florida, LLC dba SKNV
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2026 | Not classified | Florida District Office | |
| March 6, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| September 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sincerus Florida, LLC dba SKNV
- FDA Inspection 1316134 - 2026-05-29
- FDA Inspection 1263272 - 2025-03-06
- FDA Inspection 1065810 - 2018-09-17
- FDA Inspection 1017462 - 2017-06-26
- FDA Inspection 986127 - 2016-07-15
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