Warning letter
ABC Compounding Company, Inc.: warning letter of Nov 1, 2004
FDA warning letter UCM146656 · Atlanta District Office
Key facts
| Reference number | UCM146656 |
|---|---|
| Company | ABC Compounding Company, Inc. |
| Subject | Lacks Approved New Drug Application/Adulterated/Misbranded |
| Issue date | Nov 1, 2004 |
| Posted date | Nov 1, 2004 |
| Issuing office | Atlanta District Office |
| Product type | Drugs |
| CFR sections cited | 201.5, 211, 211.115, 211.192, 330.14, 201.66(b)(2), 211.22(d), 211.166(a), 210.1(a) |
| Country | 3 |
| Inspection city | Conyers |
| Inspection ZIP | 30013-1503 |
| Inspection start date | Jul 22, 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: