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


Cybernet Systems Corp. Ann Arbor, MI (1/15). Inspected 9/09/2009-10/30/2009. QSR deviations, adulterated: The firm has not designated a management representative, has not established management review procedures, and has not conducted management reviews since 2004. The MedStar System design history records do not demonstrate that the physiological data obtained from the patient is the identical data transmitted from the MedStar Collection Server. The firm documented 29 product returns involving one or more Medstar models where the product failed, but it failed to review, evaluate and investigate these complaints, etc. (MedStar System line of products including: CHF MedStar Set, COPD MedStar Set, and Diabetes MedStar Set); FDCA 501(h), 21CFR 820.20(b)(3) & (c), 820.22, 820.30(g), 820.100, 820.198, 820.80(b) (2010-DET-06)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm200389.htm

XiAn Libang Pharmaceutical Co., Ltd. Shaanxi, China (1/28). Inspected 7/27-30/09. GMP deviations, adulterated: The firm’s quality unit failed to ensure that materials are appropriately tested and the results reported. The firm used the infrared spectra for the raw material for one lot to approve and release two subsequent incoming lots. FDA says this practice is unacceptable and raises serious concerns about the integrity and reliability of the laboratory analyses conducted by the firm. The quality control unit failed to detect that infrared spectra were being substituted by a laboratory employee and were misrepresenting the actual results of the tested incoming material. In the firm’s 9/2/09 response it stated that it fired the chemist responsible for falsifying the data and removed the previous quality control manager and quality manager from Libang’s quality management team. FDA says the response is incomplete because the firm has not provided a more comprehensive plan to ensure the integrity of all data used to assess the quality and purity of APIs manufactured at the facility, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B) (WL: 320-10-01)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm200384.htm