FDA Inspection 1099307 — Stonegate Pharmacy LP
The FDA completed an inspection of Stonegate Pharmacy LP on August 9, 2019 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Austin, TX (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 |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |