FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Sep 23, 2022
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on September 23, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RC Outsourcing, LLC
- Inspection Date
- September 23, 2022
- Product Type
- Drugs
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ID · ece6b948-88aa-410f-9330-e8fa6103f2c5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1180214
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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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