Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking the link following each letter.
Repromed Fertility Center Dallas, TX (7/28). Inspected 3/27-4/2. Deviations: The firm failed to collect a communicable disease specimen for directed semen donor within seven days before or after recovery. It also failed to screen a donor of reproductive cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.80(b), 1271.75(a), 1271.80 1271.85
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm425849.htm
Karl Storz GmbH & Co. Baden-Wurrtemberg, Germany (12/8). Inspected 10/14-29/14. QSR deviations, adulterated: During the inspection, the firm did not have any design validation data to demonstrate that the cleaning brush specified in the instruction manual is appropriate for the Flex-X2 Flexible Ureteroscope, Model #112781AU1. The firm also failed to establish and maintain procedures for verifying or validating corrective and preventive actions, to ensure that such action is effective and does not adversely affect the finished device. The firm failed to develop, conduct, control and monitor production processes to ensure that a device confirms to its specifications. For example, on 10/17, the investigator observed that the operator did not use the specified brush for cleaning the intubation scope and the brush did not fit through the working channel. The device was then processed through the decontamination station and associated paperwork was stamped “Decontaminated,” etc. (endoscopes, including the Flex-X2 Flexible Ureteroscope); FDCA 501(h), 21 CFR 820.30(g), 820.100(a)(4), 820.70(a), 820.198(c)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426564.htm
Voss Plastics, Inc. San Antonio, TX (11/5). Inspected firm at 11630 Rainbow Ridge, Helotes, TX 9/8-12. QSR deviations, adulterated: The firm failed to establish procedures for validating a process whose results cannot be fully verified. The plant manager stated that he visually inspects individual units during the run to verify that the device is manufactured correctly, but the firm does not have written procedures identifying how this visual inspection would be conducted and does not specify when and how often samples will be pulled. The firm also has not established procedures to identify, document, evaluate, segregate, and disposition nonconforming products, etc. (disposable coronary by-pass cannulas); FDCA 501(h), 502(t)(2), 21 CFR 820.75(a), 820.70(a), 80(a), 820.90(a), 820.100(a), 820.198(a), 820.184, 820.22, 820.20(c), 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm426559.htm
