FDA 483 - Fresenius Kabi Oncology Limited - October 10, 2023

During an inspection from October 3-10, 2023, the FDA observed deficiencies at Fresenius Kabi Oncology Limited, a drug manufacturer located in Solan, Himachal Pradesh, India. The inspection report was issued to Arvind Kumar Sharma, Managing Director.

A key observation was the failure to establish and follow procedures designed to prevent microbiological contamination of sterile drug products. Specifically, Procedure SOP/CSP/0015, "Behavior and Aseptic Practices for Persons Working in Aseptic Area," was not adhered to. Operators were observed not keeping their entire bodies out of the path of unidirectional airflow during interventions in the (b)(4) during aseptic filling operations.

Examples cited include: - An operator repeatedly leaning over sterile product (b)(4) to change the (b)(4) tank during aseptic filling of (b)(4) Injection batch (b)(4) from August 29-30, 2023. - Operators reaching over open vials and the (b)(4) with non-sterile RABS (b)(4) during aseptic filling of (b)(4) Injection batch (b)(4) (distributed to the US market), (b)(4) Injection batch (b)(4), and (b)(4) Injection batch (b)(4). - Operators reaching over open vials with non-sterile RABS (b)(4) to perform other tasks.

These observations indicate critical