FDA 483 - Pharmedium Services LLC - December 09, 2010

An FDA Form 483 inspection revealed significant deficiencies at a facility compounding sterile preparations (CSPs). Between March 2010 and the present, the firm received approximately 11 complaints regarding Heparin-containing CSPs, citing subpotency and/or lack of therapeutic effect.

Specific complaints include: * January 8, 2010: "Heparin 25,000 Units added to 0.45% Sodium Chloride Injection (100 units/ml), lot #101029800022" for lack of therapeutic effect. * July 7, 2010: "Heparin 25,000 Units added to 5% Dextrose Injection USP (50 units/ml) 500ml Bag”, lot #101018200053" for subpotency. * May 17, 2010: "Heparin 25,000 Units added to 5% Dextrose Injection (50 units/ml), lot #101007800068" for lack of therapeutic effect.

Although complaint investigations included Certificates of Analysis from a contract laboratory indicating potency testing for Heparin using an (b)(4) method, the firm lacked data to demonstrate that this (b)(4) method