FDA inspection
Antibioticos Do Brasil Ltda: FDA inspection ending Apr 27, 2016
FDA inspection 970151 · Official Action Indicated (OAI) · Cosmopolis
Key facts
| Inspection ID | 970151 |
|---|---|
| Firm | Antibioticos Do Brasil Ltda |
| FEI number | 3004132818 |
| Address | Rod Professor Zeferino Vaz, Km 135, Jardim Itapavussu |
| City | Cosmopolis |
| Country | Brazil |
| Fiscal year | 2016 |
| Inspection end date | Apr 27, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 507258 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No 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