Amgen Statement on Jan 27 2014 FDA Warning Letter
THOUSAND OAKS, Calif. (Feb. 11, 2014)
Amgen's commitment to product quality includes the medicines we make and the needles, syringes and other constituent parts used in their administration. Medicines in conjunction with these device constituent parts are known as "combination products."
We received a warning letter from the U.S. Food and Drug Administration (FDA), dated Jan. 27, 2014, describing issues related to the device constituent parts of our combination products.
Amgen takes these issues very seriously and we have implemented changes to our procedures. We are committed to working with the FDA to take appropriate measures and provide the necessary information to address the concerns raised in the letter.
Read more about our commitment to quality.