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# Multiple Violations at BioPure Healing Products
- URL: https://www.fdaweb.com/multiple-violations-at-biopure-healing-products/
- Published: 2020-06-23T12:00:00.000Z
- Updated: 2026-09-14T16:19:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147066

A 10/15-11/8/19 FDA inspection at BHP Holdings, doing business as BioPure Healing Products, Woodinville, WA, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations for dietary supplements. A 6/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bhp-holdings-inc-dba-biopure-healing-products-597687-06172020?ref=fdaweb.com) says the company failed to review all product complaints to determine whether the complaint involves a possible failure of a dietary supplement to meet any of its specifications or any other regulatory requirement that, if not met, may result in a risk of illness or injury. The letter also lists several reasons why FDA considers some of the firm’s products to be misbranded.

According to FDA, the company’s 1/17 response provided revised procedures for product complaints and adverse event reporting, as well as a record of the training provided on the procedures. The agency says that based on the documentation provided in the firm’s 3/17 response, the agency has ongoing concerns with the firm’s review and investigation of product complaints it receives.

BioPure was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with the documentation for each step and a timetable for completion.