Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:

Health Solutions Pharmacy Center, Corvallis, OR (3/31): FDA inspected the firm in January and cited serious deficiencies in its practices for producing sterile drug products. For example, the firm failed to adequately maintain facilities and equipment necessary for the aseptic production of sterile drug products. The firm also failed to use adequate cleaning procedures. Additionally, it failed to perform adequate studies under dynamic conditions to demonstrate unidirectional airflow within the ISO-5 area. Therefore, FDA said, the products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination. To view the letter, click here.