Oregon compounding pharmacy cited for unsterile conditions
FDA has sent a warning letter to a Portland-area compounding pharmacy listing six violations, including sterile practices.
FDA has sent a warning letter to a Portland-area compounding pharmacy listing six violations, including sterile practices.
The letter was sent to Oregon Compounding Centers, Inc., in Wilsonville, Ore., which does business as Creative Compounds. Last October, Creative Compounds voluntarily recalled certain unexpired human and veterinary sterile products. At the time, company officials said they had not received any reports of product contamination or adverse events, but took the step as a precautionary measure.
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An FDA inspection of Creative Compounds in August found a lack of valid prescriptions for individually identified patients and “serious deficiencies” in the company’s manufacturing of sterile products.
“Investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, they observed that equipment and materials are not disinfected before introduction into the ISO 5 area,” the warning letter stated. “The investigators also observed operators processing sterile drug products with exposed skin on their wrists. Furthermore, investigators found that your firm failed to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed.”
The letter concludes that the violations are causing products from Creative Compounds to be produced in an environment that poses “a significant contamination risk.”
Specifically, FDA cited Creative Compounds for not having an adequate system for cleaning and disinfecting a room and equipment; not having an adequate system for monitoring environmental conditions in aseptic processing areas; and the lack of a written testing program designed to assess the stability characteristics of drug products.
FDA ordered Creative Compounds to promptly correct the violations and to provide FDA with a list of steps taken, documentation, and a timetable for corrective actions.
