FDA Inspection 1070172 — Johnson Memorial Cancer Center
The FDA completed an inspection of Johnson Memorial Cancer Center on October 19, 2018 in Enfield, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Enfield, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18948 | FDCA 501(a)(2)(A) | Disruption of airflow from personnel movement |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |