FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration

Within 5 months, the FDA has issued 8 Warning Letters to companies who failed to comply with the obligation to register production establishments. These companies are mainly located in Asia but also in France and Columbia.

Under section 510(i)(1) of the Act 21 U.S.C. § 360(i)(1), companies are required to submit registration information annually by electronic means about the manufacture of medicinal products that are imported or offered for import into the United States. Part 207 of Title 21 of the CFR lays down the requirements regarding registration and the necessary updates and changes.

Registration by electronic means must be made on the following page: FDA Electronic Drug Registration and Listing Page.

The Warning Letters are listed below:

25 January 2012: China Zhejiang Xianju Chemical Pharmaceutical Factory

28 February 2012: India Pan Drugs Limited

28 Feburary 2012: China Chinese Peptide Company

15 March 2012: France Orlane S.A.

26 March 2012: Korea Korea Pharma Company Ltd

5 April 2012: Hong Kong Peking Medicine Manufactory

15 May 2012: Columbia C.I. Farmacapsulas S.A.


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