Warning letter
Intrathecal Compounding Specialist, LLC: warning letter of Sep 15, 2020
FDA warning letter 610639 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 610639 |
|---|---|
| Company | Intrathecal Compounding Specialist, LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 15, 2020 |
| Posted date | Sep 29, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| Inspection city | Scott |
| Inspection ZIP | 70583 |
| Inspection start date | Feb 6, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: