FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Sep 27, 2024
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on September 27, 2024, issued by the Cincinnati District Office, covering human drugs.
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ID · f63e067d-fe74-47cf-8cce-74b1796c4d19
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1252006
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.42(c)(10)(v)Cleaning System
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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 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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