FDA inspection
Hetero Labs Limited (Unit V): FDA inspection ending Dec 16, 2016
FDA inspection 995278 · Official Action Indicated (OAI) · Mahabubnagar
Key facts
| Inspection ID | 995278 |
|---|---|
| Firm | Hetero Labs Limited (Unit V) |
| FEI number | 3008307735 |
| Address | Tsiic Formulation Sez, Surv. No. 439-441, 458, Polepally Village |
| City | Mahabubnagar |
| Country | India |
| Fiscal year | 2017 |
| Inspection end date | Dec 16, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 520359 |
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