FDA Inspection 1034828 — Intrathecal Compounding Specialists, LLC
The FDA completed an inspection of Intrathecal Compounding Specialists, LLC on November 17, 2017 in Scott, LA. 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
- November 17, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scott, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18939 | FDCA 501(a)(2)(A) | Highly potent drugs, prevention of cross-contamination |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18944 | FDCA 501(a)(2)(A) | Exposure of personnel in aspectic processing |
| 18947 | FDCA 501(a)(2)(A) | Personnel in aseptic processing, cleanroom gowning |
| 18951 | FDCA 501(a)(2)(A) | Personnel contact outside ISO 5 area |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |