FDA Inspection
Sincerus Florida, LLC dba SKNVSincerus Florida, LLC dba SKNV – FDA Inspection, Sep 17, 2018
Record Details
This FDA Inspection record concerns Sincerus Florida, LLC dba SKNV, with an inspection on September 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7d0a7297-c388-48ab-80ac-a7d1e7e2f53b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065810
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.110(a)(3)Mixing adequacy
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| 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 1229212 - 2024-05-23
- FDA Inspection 1017462 - 2017-06-26
- FDA Inspection 986127 - 2016-07-15
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