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

Source: https://www.keypedia.com/records/483/fresenius-kabi-oncology-limited/4fc96f2b-efac-421b-b07d-c4d4448e54de

> FDA 483 for Fresenius Kabi Oncology Limited on October 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fresenius Kabi Oncology Limited
- Inspection Date: 2023-10-10
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted at Fresenius Kabi Oncology Limited in Solan, Himachal Pradesh, India, from October 3-10, 2023, revealed significant deviations from current Good Manufacturing Practices (cGMP). The inspection resulted in 11 observations, primarily concerning aseptic processing, laboratory controls, and quality oversight.Key issues included a systemic failure in preventing microbiological contamination: operators did not follow aseptic practices, exhibited exposed skin, and exposed sterile components to non-sterile environments. Environmental monitoring records were found to be falsified, with samples reported as "no growth" despite not being collected at specified points. Aseptic process validation (smoke studies) was inadequate, failing to properly assess airflow dynamics during interventions. The company also failed to contemporaneously record critical laboratory data, specifically endotoxin test results, and neglected to review associated audit trails, raising data integrity concerns.Further observations highlighted incomplete batch production records, deficient environmental monitoring programs (including poor risk assessment for sampling locations, incorrect sampling techniques, and lack of neutralizing agents in media), and inadequate cleaning and disinfection procedures. Cleaning validation studies for shared equipment were incomplete. The quality control unit lacked adequate oversight of aseptic operations due to facility design limitations, and investigations into torn aseptic processing gloves were not thorough, omitting crucial assessments of disinfectant effects and testing frequencies.Fresenius Kabi Oncology Limited must address these observations by implementing comprehensive corrective and preventive actions to ensure the sterility, quality, and integrity of its drug products and to comply with FDA regulations.

## Related Documents

- [483 - 2023-10-10](https://www.keypedia.com/records/483/fresenius-kabi-oncology-limited/d19a7f12-f3d8-4588-ac33-b115b6673823)
- [483 - 2023-10-10](https://www.keypedia.com/records/483/fresenius-kabi-oncology-limited/fe3c67ce-6ae7-4fec-b346-4bb802c84a55)

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Company: https://www.keypedia.com/companies/fresenius-kabi-oncology-limited/d092c98c-aa35-490f-97c4-3ed02fe7dac7

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa