# FDA 483 - Biomat USA Inc - April 04, 2023

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/920d3db4-fd77-48f1-8b53-84c2a9cae56d

> FDA 483 for Biomat USA Inc on April 04, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2023-04-04
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: Talecris Plasma Resources Inc, a plasmapheresis center in Lafayette, LA, was cited for two observations during an FDA inspection. The firm failed to ensure that a contracted laboratory performing FDA-required testing for Relevant Transfusion-Transmission Infection (RTTI) maintained an active CLIA certification. Additionally, the firm did not conduct a thorough investigation after being informed that the testing laboratory's CLIA certification had expired, continuing to send blood samples for testing.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/erika-m-wilkerson/cd1c299d-c827-4d52-8e2b-719989da9991)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/5fbf4b45-3297-4af5-965b-4af7849ed313

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8