FDA Inspection
Sincerus Florida, LLC dba SKNVSincerus Florida, LLC dba SKNV – FDA Inspection, Jun 26, 2017
Record Details
This FDA Inspection record concerns Sincerus Florida, LLC dba SKNV, with an inspection on June 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 81eb4f19-f359-4717-9127-0c271547b4c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017462
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- FDCA 503B(a)(10)Drug product label, outsourcer facility
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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 |
| May 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2018 | 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 1229212 - 2024-05-23
- FDA Inspection 1065810 - 2018-09-17
- FDA Inspection 986127 - 2016-07-15
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