FDA Inspection 1129888 — Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy
The FDA completed an inspection of Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy on September 23, 2020 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Seattle, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 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 |