FDAnews Drug Daily Bulletin

Connecticut Compounder Warned on Unsanitary Conditions and More

June 21, 2017

Beacon Prescriptions, a compounding pharmacy in Southington, Conn., was warned by the FDA for unsanitary conditions and other federal violations, according to a letter sent earlier this month.

The compounder was found to be in violation of numerous cGMP standards, including failing to design the facility with control systems to prevent mix-ups and contamination; failing to calibrate or inspect equipment or maintain written records of equipment maintenance; and failing to test and keep batch records of compounded drugs, their potency and specifications.

Beacon ceased sterile operations in June 2016. But the FDA is still dissatisfied with corrective actions the compounder has taken since being issued the Form 483. The agency said it cannot evaluate the steps taken, particularly when it comes to cleaning and eliminating cross-contamination, due to a lack of supporting documentation.

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