Warning letter
Instituto Bioclon, S.A. de C.V.: warning letter of Apr 16, 2014
FDA warning letter 422773 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 422773 |
|---|---|
| Company | Instituto Bioclon, S.A. de C.V. |
| Subject | CGMP Deviations |
| Issue date | Apr 16, 2014 |
| Posted date | Apr 29, 2014 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.111, 211.192, 211.25(a), 211.25(b), 211.25(c), 211.113(b), 211.125(a), 211.160(b), 211.165(f), 211.170(b) |
| Inspection city | Cuautitlan |
| Inspection start date | Jan 14, 2014 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: