FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 392917f4-fbf4-47ec-a03f-e9d1498ea0fc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1007167
- 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 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of RC Outsourcing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | Not classified | Cincinnati District Office | Drug Quality Assurance |
| August 28, 2025 | OAI | Cincinnati District Office | Drug Quality Assurance |
| September 27, 2024 | OAI | Cincinnati District Office | Drug Quality Assurance |
| September 23, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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