Data Manipulation Cited in Leiner Warning Letter
This article was originally published in The Gold Sheet
Executive Summary
FDA's Atlanta District focused on data manipulation and inadequate testing procedures in an Aug. 28 warning letter to Leiner Health Products, Carson, Calif., based on a Jan. 22 to March 16 inspection of a Fort Mill, S.C., facility where Leiner manufactured over-the-counter products. The company has since moved OTC drug and nutritional product manufacturing operations to other facilities. During a Sept. 18 conference call, Leiner CEO Robert Kaminski attributed the firm's quality control issues to the conduct of certain Fort Mill employees, including some who have been dismissed
You may also be interested in...
Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test
Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.
Biotin And ‘Healthy Hair’: Federal Pre-emption Clips False Advertising Complaint In California
US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: