FDA Inspection
Vitti Labs, LLCVitti Labs, LLC – FDA Inspection, Mar 15, 2024
Record Details
This FDA Inspection record concerns Vitti Labs, LLC, with an inspection on March 15, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8133ff98-bb2b-4622-a4a9-d1795b634158
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1230238
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
14- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
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Other FDA inspections of Vitti Labs, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2021 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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