Investigation 9 Biotechnology

WARNING LETTER

VIA UNITED PARCEL SERVICE

Mr. YC Lei
General Manager
EPS Biotechnology Corp.
No. 8 R&D RD.III
Hsinchu Science Park
Hsinchu, Taiwan 30077

Dear Mr. YC Lei:

During an inspection of your firm located in Hsinchi City, Taiwan, on June 18, 2012, through June 21, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures glucose dehydrogenase glucose meters. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you, dated July 10, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).