In early August, inspectors from the Food and Drug Administration (FDA) visited Central Admixture Pharmacy Services in Miramar and found multiple potential violations of new drug-making safety regulations.
In November of last year, the Drug Quality and Security Act was passed, and manufacturers are trying to comply, but guidance on standards has not yet been finalized.
The Irvine-based company is the largest network of outsourcing admixture pharmacies, doing compounding at offices throughout the country.
According to a report that was posted on the FDA website, inspectors found that the San Diego lab does not perform sterility and endotoxin testing of every batch of human drug products intended to be sterile.
The firm does not adequately monitor cleanrooms, says the report. Technicians processing human drug products do not adequately cover their faces around the eyes and their shoes. Some batches of drug product purporting to be sterile are not adequately tested. There is not strict control over labeling. (There were two complaints in 2011 in which six pediatric patients were infused with mislabeled drug products.)
FDA inspectors found similar problems at three other Central Admixture facilities during the same inspection period.
The company issued a written response: "[Central Admixture Pharmacy Services] takes pride in its quality systems. Our pharmacies have been voluntarily registered with FDA for approximately 20 years before the Drug Quality and Security Act was passed. [Central Admixture Pharmacy Services] does not publicly respond to FDA inspection report specifics until the inspections are closed out.
"We recently commented on the '503B Outsourcing Facility' draft FDA guidance document for applicable current Good Manufacturing Processes (cGMPs). Although the guidance is not yet finalized, we appreciate any observations FDA makes to help us improve our quality systems wherever possible.
We have responded to the agency in writing on the recent [Central Admixture Pharmacy Services] inspections and have implemented enhancements in our procedures where necessary. We look forward to continue working with FDA as the cGMP guidance is finalized."
Although the inspection results are posted on the FDA website, the inspection observations have to be passed through higher levels, so do not represent final determinations of the agency.