# FDA 483 - BPI Labs - March 10, 2022

Source: https://www.globalkeysolutions.net/records/483/bpi-labs/a8689144-52b5-49b3-a36d-f5e644d099a7

> FDA 483 for BPI Labs on March 10, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BPI Labs
- Inspection Date: 2022-03-10
- Product Type: drugs
- Office Name: Denver District Office
- Summary: BPI Labs in Evanston, WY, was inspected by the FDA from March 7-10, 2022, resulting in 12 observations. The inspection revealed significant deficiencies across production, quality, materials, laboratory, and packaging/labeling systems, indicating a lack of fundamental GMP controls. Issues included inadequate procedures for preventing contamination, deficient batch records, unvalidated equipment and processes, and a lack of quality unit oversight and employee training.

## Related Documents

- [483 - 2019-06-12](https://www.globalkeysolutions.net/records/483/bpi-labs/b862af02-b1a1-40af-804a-f707012d2423)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

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

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