FDA EIR - Fresenius Kabi Oncology Ltd - January 18, 2013

An FDA inspection of Fresenius Kabi Oncology Ltd's Active Pharmaceutical Ingredient (API) manufacturing site in Kalyani, India, took place from January 14-18, 2013. The inspection, conducted under cGMP regulations and guided by ICH Q7, uncovered significant deficiencies in quality systems and manufacturing practices. A primary concern was the company's admission of blending and distributing finished API batches that failed to meet specifications, an issue for which management committed to submitting an FDA Field Alert report.

Key violations included widespread laboratory control issues, such as performing unofficial 'test' analyses prior to generating official results, and insecure storage of electronic raw data on local drives rather than a central server, raising data integrity concerns. The firm also failed to adequately investigate out-of-specification results, lacked complete and contemporaneous batch record documentation, and used informal 'scratch paper' records for critical GMP-related information. Furthermore, production equipment was documented as qualified despite failing pre-defined acceptance criteria, and facility deficiencies, like unsealed holes in a classified processing area, were noted.

At the inspection's conclusion, Fresenius Kabi Oncology Ltd received a 9-item FDA Form 483 detailing these observations. The company's management acknowledged the findings and committed to providing a written response outlining comprehensive corrective actions within 15 business days.