Compounding Facility Cited for Lack of Sterile Conditions

June 14, 2017

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

In a warning letter, dated June 1, 2017, FDA cited DCA, Inc. dba Beacon Prescriptions (Southington, CT) for manufacturing adulterated drug products in unsanitary conditions. The agency also said the company failed to meet Food, Drug, & Cosmetic Act requirements as a drug compounding facility.

During an FDA inspection of the company’s Southington, CT facility conducted from Oct. 12–25, 2016, investigators found that the company did not design their facility adequately to ensure separation of areas to prevent contamination and failed to clean, maintain, and sanitize equipment and utensils properly. Equipment was also not routinely calibrated, inspected, or checked, according to FDA, to assure performance. Appropriate batch testing was also not performed.

“Should you continue to compound and distribute drug products that do not meet the conditions of section 503A, the compounding and distribution of such drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the drug CGMP regulations. Before doing so, you must comply with the requirements of section 505 and 502(f)(1) and fully implement corrections that meet the minimum requirements of the CGMP regulations,” the letter stated.

Source: FDA