First-Ever Stem Cell GMP Warning Letter Cites IntelliCell
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA finds the company failed to establish procedures for a range of GMP basics, which is a problem because according to the agency the IntelliCell adipose tissue-derived stem cells are both a drug and a biologic product.
You may also be interested in...
Celltex’s Stem Cell Manufacturing To Be Regulated As A Biological Drug
FDA tells Celltex Therapeutics that its stem cell treatments are to be regulated as biologics; company contends they should be considered a human cell and tissue product.
Baxter Alerted FDA To Problem Before Receiving Warning Letter, Firm Says
The letter details problems related to Baxter's use of albumin in the manufacturing of its Isolex 300i Magnetic Cell Selection System, a device/biologic regulated as a Class III device.
Ranbaxy’s Atorvastatin Recall: Will Glass Shards Nick FDA’s Reputation?
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.