# FDA 483 - GCAM Inc - September 16, 2019

Source: https://www.globalkeysolutions.net/records/483/gcam-inc/092a5e9d-3085-4177-b1d8-a079482f9384

> FDA 483 for GCAM Inc on September 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GCAM Inc
- Inspection Date: 2019-09-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of GCAM, Inc. in San Bernardino, CA, identified a critical failure in the informed consent process for plasmapheresis and tetanus immunization programs. Physician substitutes consistently neglected to verbally explain the associated risks and hazards to donors, despite the firm's own standard operating procedures requiring such disclosures. This lapse prevented donors from having a clear opportunity to refuse the procedures, indicating a significant compliance issue.

## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

Company: https://www.globalkeysolutions.net/companies/gcam-inc/c1cfc11a-d386-4007-b083-f0de9b39675e

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