The Associated Press is reporting that the Food and Drug Administration has "cited drugmaker Bristol-Myers Squibb Co. for multiple deficiencies at its Puerto Rico manufacturing plant, including glass particles in drug vials and possible contamination of sterile drug products." In the agency's warning letter to BMS, the FDA told the company that "it could hold up approval of new products if the deficiencies are not corrected quickly." I'm glad to see that the FDA is doing its best to police the quality of the manufacturing facilities. Given what we've seen in the last several years, more could be done to improve the compliance with good manufacturing practices.
Posted by Louisville, Kentucky lawyer Larry Jones. Larry can be reached at larry@jonesward.com or by using his toll-free number 1-888-KYLAW22.
