FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on September 3, 2026, issued by the Cincinnati District Office, covering human drugs.
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ID · d8f3276b-7c31-41e3-a401-7748e1890928
Inspection Facts
- Inspection number
- 1334312
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.137(b)Storage conditions
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of RC Outsourcing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| March 31, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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