FDA Inspection
Vivimed Labs UsaVivimed Labs Usa – FDA Inspection, Mar 14, 2018
Record Details
This FDA Inspection record concerns Vivimed Labs Usa, with an inspection on March 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cf4385f6-eb7b-4e67-8fb5-a772f99c866e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044228
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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