Update
Pfizer, Amgen’s Form 483s listed among more than 100 issued by US FDA already in 2015
The majority of the warnings issued so far this year are for companies’ US sites and come from FDA’s district offices, including one for AMPAC Fine Chemicals’ Rancho Cordova, California facility following an inspection in late January, as well as one for Amgen’s Puerto Rico site following a similarly timed inspection. The University of Texas’ MD Anderson Cancer Center is also listed as having received two 483s from the FDA following two inspections in January.
Two other Amgen sites in Longmont and Boulder, Colorado, were also listed. Amgen’s Thousand Oaks, California plant also received a warning letter last year for violations related to combination products. Amgen spokeswoman Kristen Davis told us, "Following routine FDA inspections of our Colorado and Puerto Rico facilities, Amgen did receive Form 483s including some observations. We have a robust quality system and a comprehensive process to review the observations and are committed to working with the FDA to take appropriate actions. For both Colorado and Puerto Rico, Amgen has already responded to the Form 483s."
Mallinckrodt Pharmaceuticals’ US base in Missouri was also hit with a 483 following a January 8thinspection, but a company spokesperson told us the company "received final approval" from the FDA "on a new medical imaging manufacturing line at its Maryland Heights, MO facility, and expects production to begin on the line in the next several weeks."
International Inspections
The list also reveals FDA’s beefing up of its international inspections, with 483s coming to companies in Australia, Canada, China, France, India, Israel, Japan and Taiwan.
Surprisingly, the seven French sites listed led all foreign countries, and included Reckitt Benckiser’s site in Chartres and Capsugel’s site in Ploermel. Chinese companies also received six 483s, while three Indian sites were hit with letters, including one for MSN Laboratories, following an inspection in late February.
Pfizer’s Perth site, which produces sterile injectables, was also cited in a 483 from an inspection on January 30th. Joan Campion, a spokeswoman of Pfizer, did not offer any comment as to how the company plans to respond.
Pfizer previously shuttered its other Australian manufacturing site back in 2013.
