FDA Inspection
RXQ Compounding LLCRXQ Compounding LLC – FDA Inspection, Aug 8, 2017
Record Details
This FDA Inspection record concerns RXQ Compounding LLC, with an inspection on August 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 80f95709-8b1d-4cf2-997c-e5507ba56e1e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1020725
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of RXQ Compounding LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | Not classified | Cincinnati District Office | |
| September 21, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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