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Home » FDA Nails Tennessee Compounder for Lack of Endotoxin Testing
FDA Nails Tennessee Compounder for Lack of Endotoxin Testing
October 12, 2018
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.
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