Compounding Pharmacy Warned About Unsterile Conditions

FDA sent a warning letter, dated August 2, 2017, to Maple Rose Enterprises, Inc. dba Pencol Compounding Pharmacy regarding an inspection the agency performed at the company’s Denver, Colorado facility from August 8–22, 2016. The inspectors found that the company was producing products that failed to meet conditions to be exempt from provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). In addition, products were being manufactured under unsterile conditions. 

The letter stated that inspectors found products, which were supposed to be sterile, prepacked, packed, or held under insanitary conditions. Investigators observed a non-sterile cleaning agent was used on ISO 5 classified work surfaces and gaps in ceiling tiles in an aseptic production area. The company was not performing post-filtration integrity testing and did not conduct adequate studies of the effectiveness of its hoods.

Other violations noted by FDA included a failure to have written procedures to prevent microbiological contamination of product, lack of a proper cleaning and disinfecting system, failure of personnel to wear appropriate clothing, and improperly maintained equipment and facilities. The agency asked the company to detail how it intends to remedy the different noted violations.