FDA Cites Five Compounding Pharmacies for Unsterile Production
Five compounding pharmacies received warning letters from the FDA for failing to maintain sterile work environments.
Over the past two months, following inspections performed in 2015, the FDA specifically cited each pharmacy for failing to demonstrate that protective equipment met ISO 5 cleanroom requirements, and warned that products may have been produced under risk of contamination.
The agency sent warning letters to: Central Illinois Compounding, of Peoria, Ill., doing business as Preckshot Professional Pharmacy; Pacific Healthcare, of Bellflower, Calif., dba B&B Pharmacy; Techni Med, of Aurora, Ill., dba The Compounder; American Pharmacy of Illinois, of Peoria, dba Alwan Pharmacy and Compounding Center; and Kalman Health & Wellness, of Peoria, dba Essential Wellness Pharma.
Pacific Healthcare and Techni Med were also cited for providing drug products without valid prescriptions for individually identifiable patients.
In addition, Techni Med was found to be producing domperidone products until May 12, 2015. Domperidone, also known by the brand name Motilium, is not approved for sale within the U.S.
Investigators also noted, in the letter dated July 29, that manufacturing personnel did not wear appropriate clothing to protect products from contamination, and that gloves were not sampled as part of an aseptic environmental monitoring program, according to the FDA’s Current Good Manufacturing Practice regulations.
Techni Med informed investigators during its inspection that it had ceased compounding and distributing products containing domperidone, but the FDA still recommended evaluating products previously produced under the observed inadequate conditions.
At Pacific Healthcare, investigators observed “poor aseptic practices, including an operator disinfecting his gloves with non-sterile isopropyl alcohol while performing aseptic operations as well as an operator entering his head with exposed skin into the ISO 5 work zone,” the Sept. 2 letter said.
Environmental samples identified microbial contamination, including spore-forming bacteria, in aseptic processing areas, the FDA said. Investigators noted that Pacific Healthcare did not use a sporicidal agent, and used non-sterile disinfectants and wipes as part of its disinfection program.
Pacific Healthcare decided to cease sterile compounding operations after receiving the FDA’s 483 in September 2015. In October 2015, the company recalled all compounded sterile drug products within expiry. However, the FDA requested confirmation that the company does not intend to resume production, or if it does, to list specific steps taken to correct any violations beforehand.
At Essential Wellness, agency inspectors noted stained HEPA filters in the laminar airflow hoods, and that environmental samples from the facility indicated the presence of spore-forming bacteria.
Essential Wellness ceased production in August 2015 and issued a voluntary recall of its sterile products following the FDA’s inspection. The FDA is asking the firm to undertake a comprehensive assessment of its operations before resuming the production of sterile drugs.
For all five compounding pharmacies, the FDA recommended the use of a third-party consultant with expertise in sterile drug processing, and that each pharmacy undergoes a comprehensive assessment of their aseptic procedures.
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