# FDA 483 - Genetech Inc - June 22, 2018

Source: https://www.keypedia.com/records/483/genetech-inc/8ea00326-5d94-49c7-a6f2-4d44df31d881

> FDA 483 for Genetech Inc on June 22, 2018. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genetech Inc
- Inspection Date: 2018-06-22
- Product Type: Biologics
- Office Name: Los Angeles District Office
- Summary: Genetech, Inc., an umbilical cord blood facility in San Diego, CA, received an FDA Form 483 following an inspection from June 18 to June 22, 2018. The inspection revealed ten significant observations primarily related to deficiencies in quality management, donor eligibility determination, and aseptic processing controls for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Key issues included the absence of documented donor eligibility determinations and inadequate review of medical records from cord blood suppliers, with some providing only a certificate of analysis. The company used communicable disease agent tests that were not FDA-licensed or approved for donor screening, and specific assays used were unsuitable for HCT/P donors. Furthermore, Genetech, Inc. lacked established procedures for donor eligibility, operated without a functional quality control unit, and failed to validate critical processes like aseptic processing and cleaning. Environmental and personnel monitoring were deficient, and batch production records did not consistently document all significant processing steps. Products were assigned a one-year expiration date without supporting stability data, and essential distribution records were entirely missing.

These observations indicate systemic non-compliance with regulatory requirements for HCT/Ps, encompassing donor screening, quality systems, process control, and record-keeping. Genetech, Inc. is expected to submit a comprehensive response outlining corrective and preventive actions to address these deficiencies and ensure future compliance.

## Related Documents

- [483 - 2018-06-22](https://www.keypedia.com/records/483/genetech-inc/6f95c3f2-4496-43cf-b8af-ac6d10461b25)

## Related Officers

- [Tania Y. Hall](https://www.keypedia.com/people/tania-y-hall/94f342b2-a5f3-4ff1-ae5a-7f75fefe2214)

Company: https://www.keypedia.com/companies/genetech-inc/00af7a0b-75ce-4c2a-865d-6580b0ff15e5

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b