Warning letter
Balchem Corporation [ARCHIVED]: warning letter of Dec 22, 2009
FDA warning letter 70123 · Chicago District Office
Key facts
| Reference number | 70123 |
|---|---|
| Company | Balchem Corporation [ARCHIVED] |
| Subject | Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals |
| Issue date | Dec 22, 2009 |
| Posted date | Dec 22, 2009 |
| Issuing office | Chicago District Office |
| Product type | Drugs |
| CFR sections cited | 211.113(a), 211.63, 210.3(b)(9), 211.110(c) |
| Inspection city | Channahon |
| Inspection ZIP | 60410 |
| Inspection start date | May 20, 2009 |
| 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: