FDA inspection
Instituto Bioclon, S.A. de C.V.: FDA inspection ending Jan 23, 2014
FDA inspection 864105 · Official Action Indicated (OAI) · Cuautitlan
Key facts
| Inspection ID | 864105 |
|---|---|
| Firm | Instituto Bioclon, S.A. de C.V. |
| FEI number | 3007581821 |
| Address | Av. 16 De Septiembre Km 3.5 Santa Maria Huecatitla, Cuautitlan |
| City | Cuautitlan |
| Country | Mexico |
| Fiscal year | 2014 |
| Inspection end date | Jan 23, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
| Warning letter | 422773 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data