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Pharmaceuticals / Inspections and Audits

FDA Cites Five Compounding Pharmacies for Risk of Adulteration

Sept. 20, 2016

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.

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