Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.

George J. Brewer, MD Univ. of Michigan Medical School Ann Arbor, MI. Inspected 5/20 and 6/9/08. The investigator failed to obtain informed subjects’ consent and continued to perform research activities during timeframes when the IRB’s study approval was expired. He also failed to maintain adequate and accurate records for disposing the investigational drug, etc. (drug study); 21 CFR 312.60, 312.66, 312.62(a)&(c), 312.53(c)(1), 312.56(a), 312.57(a)&(c) (No Code)

http://www.fda.gov/foi/warning_letters/s7088c.pdf

Haelan Products, Inc. Woodinville, WA (1/15). Inspected 9/10-11/08 and an FDA investigator collected the firm's label for the product Platinum Formula Haelan 951 Fermented Soy Beverage. Unapproved new drug, misbranded: Although the product label and Web site describe Haelan 951 as a “beverage” (i.e., a conventional food) or “nutritional supplement,” promotional claims on the Web site caused the product to be a drug. Even if the product did not include claims that caused it to be a drug, Haelan 951 would still be misbranded as a food under FDCA 403(a)(1) because of the following statement on the Web site: “Haelan 951 is approved by the Food and Drug Administration (FDA) for distribution as a nutritional supplement.” This statement is false and misleading because FDA does not approve distribution of conventional foods or dietary supplements, etc. (Haelan 951) FDCA 505(a), 502(f)(1), 403(q) (SEA 09-10)

http://www.fda.gov/foi/warning_letters/s7091c.pdf

Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. Hanzhong, China (1/31/08) Inspected the API manufacturing facility 9/3-6/07. Adulterated: The quality unit failed to ensure that its organizational structure, procedures, processes, resources, and activities are adequate to ensure that APIs will meet their intended specifications for quality and purity. For example, API batch #0706004 was released by the QAU and distributed to the U.S. before the process validation report and the stability data were reviewed and approved to show that the process was validated and the product was stable. The firm’s response to this was inadequate because it failed to indicate what further efforts would be undertaken to establish a validated process. Calibration of measuring devices was not traceable to the national standards. The company failed to maintain the facility and utility systems in the steam valve to a tank was observed to leak steam constantly, etc. (APIs); FDCA 501(a)(2)(B) (No Code)

http://www.fda.gov/foi/warning_letters/s7090c.pdf