FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.
The warning letter and deficiencies cited by FDA have major ramifications beyond Pfizer too. The letter has delayed the marketing of Momenta’s generic version of Teva’s blockbuster multiple sclerosis drug Copaxone (glatiramer), which brought in more than $4 billion in revenue for Teva each of the last four years.
Warning Letter
FDA officials inspected the site from 16 May to 8 June 2016 and noted multiple complaints of cardboard contaminants in vials of vancomycin hydrochloride for injection and though the company recalled one lot associated with the particulates, FDA says, “you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. Moreover, you received additional complaints about the same problem in the intervening time period but failed to take further action.”
Other complaints about particulate matter were found in “an unspecified number of vials of ketorolac tromethamine injection” but FDA said Pfizer’s investigation was inadequate, partially because the company did not provide a scientific rationale for selecting only a few vials for testing for particulate and not explaining the nature and purpose of the testing.
FDA also criticized Hospira for its lack of “defect limits for visual inspections,” which “may have resulted in the release of products that otherwise would not have been distributed.”
Pfizer’s subsidiary was further cited for “multiple examples of practices that represent significant risks to the sterility of your finished products.”
The violations cited were also similar to other CGMP violations at other facilities in Pfizer’s network in India, Italy, Australia and elsewhere in the US.