FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Aug 28, 2025
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on August 28, 2025, issued by the Cincinnati District Office, covering human drugs.
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ID · 77accfbc-f891-402e-94bc-860afdcdae04
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1279818
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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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 |
| 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 |
| March 31, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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