# FDA 483 - Biomat USA Inc - July 27, 2018

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/24a4b27d-13be-461d-8e84-a5510dc531c6

> FDA 483 for Biomat USA Inc on July 27, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2018-07-27
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Grifols Reseda, a plasma center in Reseda, CA, from July 25-27, 2018, identified a significant failure to comply with reporting requirements. The firm repeatedly failed to submit biological product deviation reports (BPDRs) to CBER within the mandated 45-day period. This included critical delays in reporting cases involving donors who tested positive for Hepatitis B and C, as well as issues related to donor eligibility.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/00e8d4c4-a344-4ec5-b6ed-ae0260ef0c9e

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