US FDA says compounder used non-sterile wipes during sterile drug production
US regulators inspected Innovative Intrathecal Solutions, Inc, dba Innovative Compounding Pharmacy’s site from October 2 to December 9, 2017.
According to the warning letter, published last week, investigators observed violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and “serious deficiencies in [the company’s] practices for producing sterile drug products”.
In particular, drug products intended or expected to be sterile, were “prepared, packed, or held under insanitary conditions” and at risk of being contaminated by filth, wrote the agency.
The inspectors noticed an “operator using a non-sterile wipe to clean the interior surfaces on an ISO-5 work area, and the rubber stopper of a product vial, during the production of a sterile drug product”.
In addition, ‘difficult to clean’ items were identified in the firm’s ISO 7 classified cleanroom, such as a computer keyboard and a hand-held calculator.
The agency also flagged the sanitary condition of buildings used in the manufacture, processing, packing or holding of drug products, and told the firm certain staff members were not dressed in clothing specifically designed to prevent drug products from contamination.
Regarding drug prescriptions, the investigation revealed the compounder did not receive valid prescriptions for ‘individually-identified’ patients, for all products.
“The ineligible drug products you compounded are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses,” wrote the agency.
The company did not respond to a request for comment.
