# FDA 483 - BPI Labs LLC - April 30, 2021

Source: https://www.globalkeysolutions.net/records/483/bpi-labs-llc/69fc33ad-b67c-4880-a657-dd7fb2d6c393

> FDA 483 for BPI Labs LLC on April 30, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BPI Labs LLC
- Inspection Date: 2021-04-30
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BPI Labs LLC in Largo, FL, a sterile drug manufacturer and 503B outsourcing facility, revealed multiple deficiencies in equipment qualification, supplier management, and risk analysis. The firm failed to install and qualify labeling equipment, adequately evaluate suppliers for critical components, and conduct comprehensive risk analyses for its combination products. These observations indicate significant issues in the firm's quality system and compliance with regulatory requirements.

## Related Documents

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## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Recall Coordinator](https://www.globalkeysolutions.net/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)
- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/bpi-labs-llc/3c43cb39-35d9-4866-83dc-7bc12ae51c8a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6