FDA inspection

Enantiotech Corporation Limited: FDA inspection ending Dec 7, 2018

FDA inspection 1074913 · Voluntary Action Indicated (VAI) · Zhongshan

Key facts

Inspection ID 1074913
Firm Enantiotech Corporation Limited
FEI number 3007953165
Address Zhongshan Torch Hi-Tech, No. 6 Zhongjing Rd; Industrial Development Zone
City Zhongshan
Fiscal year 2019
Inspection end date Dec 7, 2018
Classification Voluntary Action Indicated (VAI)
Project area Generic Drug Evaluation
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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