FDA Inspection
Infusion Options, Inc.Infusion Options, Inc. – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns Infusion Options, Inc., with an inspection on June 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ce33fcf7-d5aa-4ba7-97e1-df2142751b93
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012329
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- FDCA 503B(a)(10)Drug product label, outsourcer facility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Infusion Options, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2019 | Not classified | New York District Office | Drug Quality Assurance |
| April 23, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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