FDA 483 - College Pharmacy, Inc. - May 28, 2015

The FDA Form 483 details deficiencies at a compounding pharmacy. Environmental monitoring in aseptic processing areas is inadequate; microorganism identification is not consistently performed for all CFUs, as seen with gloved finger samples on 3/11/2015 (2 cfu) and 8/27/2014 (1 cfu) where identification was omitted. Procedures for documented smoke studies are lacking, with no visual records for lyophilization or ISO 5 laminar flow clean benches to confirm proper airflow. Dynamic environmental monitoring (particulate, surface, viable air sampling) is not consistently conducted during aseptic filling.

Sterilization process validation is incomplete, with no media fills performed for lyophilized products (e.g., Glutathione, HCG, DPN Inj) or eye drops (e.g., Glutathione/Vitamin C/DMSO Ophthalmic Soln). The lyophilization process for compounded drugs like Glutathione, HCG, and DPN is partly conducted in ISO 7 classified air, which is inadequate. Bioburden testing of product formulations (except pellets) is not performed, and limits are not established.

Sterility testing procedures are deficient: growth promotion tests for media are not conducted, method suitability testing was only performed on two products, and Out-of-Specification procedures are absent. A second attempt at sterility testing is permitted without proper controls. Cleaning and disinfection of aseptic processing equipment are deficient, as non-sterile wipes are used with sterilized alcohol