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.


Avlon Industries Melrose Park, IL (1/19). Inspected 3/8-15/06. Company failed to conduct its study under an IND or to assure IRB review. The company also failed to protect the subjects’ legal rights because the release document provided to the subjects contained exculpatory language through which the subject is made to waive or appear to waive legal rights, or releases or appears to release the investigator, the sponsor, the institution, and its agents from liability for negligence, etc. (drug study); 21CFR 312.20, 56.103(a), 50.20, 50.25, 312.50, 312.23, 50.25 (07-HFD-45-0102)
http://www.fda.gov/foi/warning_letters/g6217d.pdf

Levitronix LLC Waltham, MA (1/19). Inspected Zurich, Switzerland 9/26-29/06. QSR deviations, adulterated: The company failed to establish and maintain adequate procedures for implementing corrective and preventive action. For example, the SOP does not include requirements for appropriate statistical methodology to detect recurring quality problems. The company also failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints to ensure that they are processed in a uniform and timely manner. It failed to establish and maintain adequate procedures for design input to ensure that the design requirements relating to a device are appropriate and address its intended use, etc. (Levitronix CentriMag Extracorporeal Blood Pumping System and the Levitronix CentriMag Back-up Console); FDCA 501(h), 21CFR 820.100(a), 820.198(a)(1), 820.198(e)(7), 820.50(a), 820.30(b)&(c)&(e)& (f)&(i), 820.72(a), 820.184(e), 820.20(c), 820.75(a), 820.70(e) (No Code)

http://www.fda.gov/foi/warning_letters/g6215d.pdf