FDA inspection

Gelnova Laboratories (India) Private Ltd.: FDA inspection ending Feb 1, 2019

FDA inspection 1081178 · Voluntary Action Indicated (VAI) · Navi Mumbai

Key facts

Inspection ID 1081178
Firm Gelnova Laboratories (India) Private Ltd.
FEI number 3010673418
Address C - 125 Ttc Industrial Area, T T C M I D C Mahape Road
City Navi Mumbai
Country India
Fiscal year 2019
Inspection end date Feb 1, 2019
Classification Voluntary Action Indicated (VAI)
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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