FDA Inspection
Vitae Enim Vitae Scientific, Inc.Vitae Enim Vitae Scientific, Inc. – FDA Inspection, Feb 27, 2019
Record Details
This FDA Inspection record concerns Vitae Enim Vitae Scientific, Inc., with an inspection on February 27, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 97f40aae-4be5-47bd-b055-005d8015c1ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080750
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Vitae Enim Vitae Scientific, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 7, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| September 22, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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