FDA Nails Tennessee Compounder for Lack of Endotoxin Testing

The FDA knocked compounding pharmacy People’s Custom Rx and Clinical Care with a Form 483, taking the firm to task over unsanitary practices and a failure to conduct endotoxin testing on finished products.

During the agency’s investigation of the Memphis, Tennessee, facility — which lasted from June 25 to July 2 — the inspector observed an employee engaging in unsanitary behavior while aseptically processing a lot of injectable Dexamethasone. Specifically, after moving her gloved hands outside an ISO 5 area, she did not re-sanitize them before placing them back under the ISO 5 hood. The same employee was also seen wearing a face mask and hairnet that left her forehead partially exposed while it was inside the ISO 5 hood.

One of the firm’s magnahelic gauges, which measures differential pressure between its ISO 8 anteroom and an unclassified area, had a reading of zero, the agency said. In addition, a gauge that monitored pressure between the facility’s ISO 7 cleanroom and ISO 8 anteroom was not functioning. During the time of observation, an operator was preparing two lots of intrathecal drug product under an ISO 5 hood that was given to patients — morphine/baclofen intrathecal and morphine/bupivacaine intrathecal.