FDA Inspection
Infusion Options, Inc.Infusion Options, Inc. – FDA Inspection, Jun 25, 2019
Record Details
This FDA Inspection record concerns Infusion Options, Inc., with an inspection on June 25, 2019, issued by the New York District Office, covering human drugs.
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ID · bca5d86f-9680-48b4-9ea8-1a531ca4e673
Inspection Facts
- Inspection number
- 1094109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.28(c)Unauthorized Personnel in Limited Access Areas
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Other FDA inspections of Infusion Options, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 23, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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