FDA inspection

Hetero Labs Ltd. - Unit IX: FDA inspection ending May 14, 2019

FDA inspection 1089874 · Official Action Indicated (OAI) · Visakhapatnam

Key facts

Inspection ID 1089874
Firm Hetero Labs Ltd. - Unit IX
FEI number 3009093782
Address N. Narasapuram Village, Nakkapally
City Visakhapatnam
Country India
Fiscal year 2019
Inspection end date May 14, 2019
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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