Shanghai Desano Chemical Pharmaceutical Co., Ltd. FDA Warnin
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 14, 2017
Executive Summary
The FDA issued a warning letter to Shanghai Desano Chemical Pharmaceutical Co., Ltd. on June 14, 2017 citing regulatory violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Shanghai Desano Chemical Pharmaceutical Co., Ltd.'s operations or product claims.
Potential Health Risks
Jinliang Li, Ph.DChairman of the BoardShanghai Desano Chemical Pharmaceutical Co., Ltd.1479 Zhangheng RoadZhangjiang High-Tech ParkShanghai 201203, China
Location: Shanghai Desano Chemical Pharmaceutical Co., Ltd.No. 417 Binhai Road, Laogang Town,Pudong District, Shanghai 201302, China
The Food and Drug Administration has completed an evaluation of Shanghai Desano Chemical Pharmaceutical Co., Ltd. (FEI 3006895951) corrective actions in response to Warning Letter 320-16-18, dated June 06, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
Regulatory Context
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
If you have any questions regarding this letter, you may contact me at the above address or number: (301) 796-5339.
Cesar E. MattoCompliance OfficerDivision of Drug Quality I
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Shanghai Desano Chemical Pharmaceutical Co., Ltd.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Shanghai Desano Chemical Pharmaceutical Co., Ltd. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
- What should I do if I've used Shanghai Desano Chemical Pharmaceutical Co., Ltd. products?
- If you have used products from Shanghai Desano Chemical Pharmaceutical Co., Ltd. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter