# FDA 483 - Chara Biologics, Inc. - August 16, 2024

Source: https://www.keypedia.com/records/483/chara-biologics-inc/0377f0bb-e0f5-476e-8c8d-4cf0b1004290

> FDA 483 for Chara Biologics, Inc. on August 16, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chara Biologics, Inc.
- Inspection Date: 2024-08-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Chara Biologics, Inc. in Chatsworth, CA, a stem cell manufacturer, was inspected by the FDA from July 23 to August 16, 2024. The inspection revealed significant deficiencies across multiple areas, including lack of product traceability, inadequate donor eligibility determination, absence of written procedures for manufacturing and quality control, and improper handling of expiration dates and labeling. These issues indicate a severe lack of control over the identity, strength, purity, and quality of their drug products, particularly CharaCore, CharaExo, and CharaOmni.

## Related Documents

- [WARNING_LETTER - 2024-08-16](https://www.keypedia.com/records/warning_letter/chara-biologics-inc/11b6afe2-5663-478f-ad88-914d6734eb39)

## Related Officers

- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/chara-biologics-inc/1dcf1d04-8a40-4431-8236-97461bcf74eb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6