# FDA 483 - LONZA HAYWARD - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/lonza-hayward/02944536-57fa-4709-92c4-4ef98beaa3b4

> FDA 483 for LONZA HAYWARD on Unknown Date. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LONZA HAYWARD
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Lonza Biologics Inc. in Hayward, CA, revealed significant deficiencies in their manufacturing and quality control processes. Key issues included a lack of standard operating procedures for cell bank homogeneity testing, inadequate accountability and investigation of working cell bank discrepancies, and poor identification of materials and equipment. Additionally, the firm's third-party materials warehouse exhibited multiple issues related to space, material storage, and labeling.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

Company: https://www.globalkeysolutions.net/companies/lonza-hayward/19536399-39d9-4537-bb77-8176c6193eea

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df