FDA Inspection 1038731 — Infusion Partners, LLC
The FDA completed an inspection of Infusion Partners, LLC on January 26, 2018 in Canfield, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Canfield, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |
| 18948 | FDCA 501(a)(2)(A) | Disruption of airflow from personnel movement |
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18951 | FDCA 501(a)(2)(A) | Personnel contact outside ISO 5 area |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |