Warning letter
Custom Compounding Centers: warning letter of Dec 23, 2003
FDA warning letter UCM147890 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM147890 |
|---|---|
| Company | Custom Compounding Centers |
| Subject | Pharmacy Compounding/GMP for Finished Pharmaceuticals |
| Issue date | Dec 23, 2003 |
| Posted date | Dec 23, 2003 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 210, 211.80, 211.100, 312, 211.165(a), 211.166(a), 211.170(b), 211.137(a) |
| Country | 3 |
| Inspection city | Little Rock |
| Inspection ZIP | 72211-3729 |
| Inspection start date | Aug 29, 2003 |
| 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: