FDA Inspection
Sincerus Florida, LLC dba SKNVSincerus Florida, LLC dba SKNV – FDA Inspection, Mar 6, 2025
Record Details
This FDA Inspection record concerns Sincerus Florida, LLC dba SKNV, with an inspection on March 6, 2025, issued by the Florida District Office, covering human drugs.
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ID · fb935f5d-b31d-4113-bb68-d7d5e4a026ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263272
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- FD&C Act 503B(a)(10)(B)Drug product container, fails to include
- FD&C Act 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
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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 | |
| 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 |
| 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 1229212 - 2024-05-23
- FDA Inspection 1065810 - 2018-09-17
- FDA Inspection 1017462 - 2017-06-26
- FDA Inspection 986127 - 2016-07-15
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