News

Article

Compounding Facility Cited for Lack of Sterile Conditions

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

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content