Warning letter
Carolina Infusion: warning letter of May 22, 2023
FDA warning letter 659408 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 659408 |
|---|---|
| Company | Carolina Infusion |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | May 22, 2023 |
| Posted date | Jun 13, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.115, 200.10(b), 210.1(b) |
| Inspection city | Ridgeland |
| Inspection ZIP | 29936 |
| Inspection start date | Jul 18, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: