FDA Inspection
RC Compounding Services, LLCRC Compounding Services, LLC – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns RC Compounding Services, LLC, with an inspection on February 16, 2018, issued by the Cincinnati District Office, covering human drugs.
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ID · 1fc42668-5be4-431f-a960-01b0be1edca5
Inspection Facts
- Inspection number
- 1041801
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- FDCA 501(a)(2)(A)Air flow quality, higher classified area
- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
- FDCA 501(a)(2)(A)Highly potent drugs, prevention of cross-contamination
- FDCA 501(a)(2)(A)Improper gowning, contamination
- FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
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Other FDA inspections of RC Compounding Services, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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