FDA Inspection 1149221 — Intrathecal Compounding Specialists, LLC
The FDA completed an inspection of Intrathecal Compounding Specialists, LLC on August 19, 2021 in Scott, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scott, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |