FDA inspection

Hetero Labs Ltd. Unit VI: FDA inspection ending Nov 15, 2016

FDA inspection 999209 · Official Action Indicated (OAI) · Mahaboob Nagar

Key facts

Inspection ID 999209
Firm Hetero Labs Ltd. Unit VI
FEI number 3008294355
Address Unit-Vi, Sy. No. 410, 411, Tsiic Formulation SEZ, Polepally Village, Jadcherla Mandal
City Mahaboob Nagar
Country India
Fiscal year 2017
Inspection end date Nov 15, 2016
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No 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

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