# FDA CRL - Sandoz Inc - Unknown Date

Source: https://www.keypedia.com/records/crl/sandoz-inc/71b33079-8fec-4638-be11-26d221366c8e

> FDA CRL for Sandoz Inc on Unknown Date. Product: BLA. Access full analysis and detailed observations.

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## Details

- Record Type: CRL
- Company Name: Sandoz Inc
- Product Type: BLA
- Summary: Sandoz Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA 761271) for EG12014, indicating the application cannot be approved in its present form. The main issues arise from significant deficiencies identified during Current Good Manufacturing Practices (CGMP) and pre-license inspections of the drug product manufacturing facility. Key violations include unaddressed facility inspection deficiencies, requiring satisfactory responses to the FDA Form 483 and potential reinspections to confirm CGMP compliance. The agency also noted product quality deficiencies, specifically related to CMC Microbiology.

Furthermore, the FDA reserved comments on proposed prescribing information, carton/container labeling, and the proprietary name until other deficiencies are resolved. Sandoz is required to provide a comprehensive safety update, incorporating new nonclinical and clinical safety data, detailed changes in the safety profile, retabulations of adverse events, and worldwide safety experience.

Under the regulatory framework of 21 CFR 601.3(b), Sandoz must fully address all identified deficiencies and resubmit the application within one year. The resubmission must be clearly marked as a complete response. The product cannot be legally marketed until written approval is granted by the FDA.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/sandoz-inc/c305bf3f-a0db-4e7e-8bdf-cbf0f8cc4be9)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/sandoz-inc/572ac433-b2ae-463e-8955-cc529601bd70)

## Related Officers

- [Raheel Khan, MBA, RAC](https://www.keypedia.com/people/raheel-khan-mba-rac/0ff1149f-56d4-4a5e-8826-4f1a5e56571f)

Company: https://www.keypedia.com/companies/sandoz-inc/754ea1c4-cac0-44a3-a842-fdecd9df9ecd