Warning letter

Jilin Shulan Synthetic Pharmaceutical Co. Ltd.: warning letter of May 14, 2018

FDA warning letter 546328 · Center for Drug Evaluation and Research

Key facts

Reference number 546328
Company Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
Subject CGMP/APIs/Adulterated
Issue date May 14, 2018
Posted date May 29, 2018
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Jilin
Inspection start date Nov 7, 2017
Letter on fda.gov fda.gov

At a glance

  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

Browse all FDA warning letters