In the form 483 the US Food and Drug Administration (FDA) outlines the quality problems that led to it sending a warning letter to APP last month. The first part of the 18-page 483, which the FDA wrote immediately after its July inspection of the New York plant, focuses on how APP handled complaints.
“More than 400 customer complaints have been received since January 2010”, the FDA wrote in its 483 to APP, “[but] you have not performed an initial impact assessment [on any] as required”.
Already this year the FDA has criticised the handling of complaints at Novartis, Merck KGaA, and APP. In each case the failure to do timely, thorough investigations of complaints contributed to the FDA sending a warning letter.
Many complaints to APP centred on vials. Some were cracked or leaking, others contained hairs or insects. In the 483 the FDA highlights six complaints and the shortcomings of APP investigations into the issues.
“Your statement of batch manufacturing records review is vague. It does not mention specific areas reviewed that may have direct or indirect impact in relation to the nature of the complaint”, the FDA wrote.
One complainant returned 407 vials of heparin due to missing vial labels. Another sent back 29 units of calcium gluconate because of possible fungal growth. In both cases the FDA criticised the lack of a paper trail to show what happened to the returned products.
After receiving a warning letter last month Fresenius Kabi, the owner of APP, said: “[We have] made significant progress in collaboration with the FDA in remedying these issues [and] full confidence in the quality of the products.”