Warning letter
Custom Compounding Center: warning letter of Mar 16, 2016
FDA warning letter 481888 · Dallas District Office
Key facts
| Reference number | 481888 |
|---|---|
| Company | Custom Compounding Center |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 16, 2016 |
| Posted date | Apr 5, 2016 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 211.113(b), 211.42(c)(10)(iv), 211.28(a), 211.25(a), 201.115 |
| Inspection city | Little Rock |
| Inspection ZIP | 72211 |
| Inspection start date | Mar 30, 2015 |
| Letter on fda.gov | web.archive.org |
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: