# BPI Labs – FDA 483, Jun 12, 2019

Source: https://www.keypedia.com/records/483/bpi-labs/b862af02-b1a1-40af-804a-f707012d2423

> FDA 483 for BPI Labs on June 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BPI Labs
- Inspection Date: 2019-06-12
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of BFT Labs, Inc. in Evanston, WY, a medical device manufacturer, from June 10-12, 2019, revealed extensive deficiencies across its quality system. The firm lacked established procedures for critical processes such as validation, medical device reporting, supplier management, CAPA, design change, document control, quality audits, and management review. Additionally, issues were identified with device history records, equipment maintenance, environmental controls, and personnel training, indicating a systemic failure to maintain compliance for its personal lubricant products.

## Related Documents

- [483 - 2022-03-10](https://www.keypedia.com/records/483/bpi-labs/a8689144-52b5-49b3-a36d-f5e644d099a7) — date: March 10, 2022

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/bpi-labs/5d946aae-dbb7-4aeb-aabd-768e0ab6b9ff

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face