Changzhou Qianhong Bio-Pharma Co., Ltd 6/4/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Silver Spring, MD 20993 |
WL: 300-12- 16
June 4, 2013
Mr. Yaofang Wang
Changzhou Qianhong Bio-Pharma Co., Ltd
No.192 Huanghe West Road, Xinbei District
Changzhou, Jiangsu, China 213032
Dear Mr. Wang:
The United States Food and Drug Administration (FDA) has reviewed entries regarding shipments of drugs into the United States from the establishment listed above, as well as information on file concerning your establishment’s drug registration and listing. This review revealed that you have not fulfilled your registration obligations under the Federal Food, Drug, and Cosmetic Act (the Act). Our records indicate you have manufactured prepared, propagated, compounded, or processed drugs that were being imported or offered for import into the United States during a time you were not registered.
Under section 510(i)(1) of the Act (21 U.S.C. § 360(i)(1)), you are required to submit registration information initially annually, during the period from October 1 through December 31, by electronic means for each foreign establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the United States. The failure to register in accordance with this provision is a prohibited act under section 301(p) of the Act (21 U.S.C.§ 331(p)).
In addition, a drug offered for import may be refused admission under section 801(a)(3) of the Act (21 U.S.C. § 381(a)(3)), if the drug appears to be adulterated or misbranded. Under section 502(o) of the Act (21 U.S.C. § 352(o)), the failure to register an establishment as required by section 510, to list a drug as required under section 510(j) or to supply certain notice or information about the drug required under section 510, renders a drug misbranded. FDA regulations in 21 CFR part 207 specify the requirements for registering and listing drugs.
To remedy the above-mentioned violation of the Act and ensure that your drugs are not subject to refusal of admission to the United States on the bases identified above, you should take action immediately to register the establishment at No.192 Huanghe West Road, Xinbei District Changzhou, Jiangsu, China 213032, and ensure that you have properly listed drugs being offered for import to the United States that are manufactured there.
Within fifteen working days of receipt of this letter, please notify this office in writing of the actions taken to correct this violation of the Act. If you intend to continue to produce drugs that are being imported or offered for import into the United States, you must complete the required registration and listing. In such case, please inform us that you have fulfilled these requirements in response to this letter. If you cannot complete the required corrective action within fifteen business days, state the reason for the delay and the date by which you will have completed the correction. If you instead intend to cease producing drugs that are being imported or offered for import into the United States, please notify us of this intent and provide notice of discontinuance of production of those drugs in accordance with section 510(j)(2) of the Act (21 U.S.C. § 360(j)(2)) and 21 CFR part 207. Please direct correspondence to:
Donovan F. Duggan
Center for Drug Evaluation and Research/Office of Compliance
White Oak, Building 51, Rm 2260
10903 New Hampshire Ave
Tel: (301) 796-3100
Fax: (301) 847-8747
FDA no longer accepts paper submissions for Registration and Listing. Establishment registration information or renewal should be submitted via Structured Product Labeling (SPL) using the new electronic system. For information on how to use the electronic system visit: http://www.fda.gov/eDRLS
Deputy Director for Policy and Analysis
Office of Compliance
Center for Drug Evaluation and Research