Compounder Gets Warning Letter for Poor Cleaning Practices, GMP Violations

The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility.

The warning letter issued to Beacon Hill Medical Pharmacy stemmed from a July 2013 inspection of the company’s Southfield, Mich., facility.

Investigators discovered that an area used to perform aseptic operations was cleaned with soap, tap water and non-sterile disinfectants. “In addition, non-sterile gloves were used to manually stopper vials, and partially stoppered, aseptically filled vials were transferred unprotected to a table in an unclassified area,” says the Sept. 24 letter released recently.

The FDA also found the compounder’s cleanroom hoods offered inadequate protection and the facility failed to establish an adequate stability testing program.

The agency issued a Form 483 last year to Beacon Hill, which provided a lackluster response. The compounder told the agency that it follows U.S. Pharmacopeia regulations regarding aseptic processing, and doesn’t need to abide by agency good manufacturing practice (GMP) regulations. The defense is commonly used by compounders not used to strict gowning and aseptic processing requirements outlined in GMPs.

Beacon Hill last year did recall its sterile products and ceased production of sterile injectable suspension drugs. While the compounder told the FDA in February that it would close its doors, the agency discovered in June that it was compounding non-sterile drugs. A lawyer for the business told the FDA that Beacon Hill is in the process of winding down production and shutting its doors.

The agency strongly recommended Beacon Hill conduct a comprehensive assessment of its quality system if it decides to start producing sterile drugs again. Beacon Hill is the latest compounder to get chided for quality failings as the FDA makes full use of new authority over larger facilities.
The compounder did not return a request for comment as of press time.

Problems with equipment maintenance, cleaning and calibration are among the FDA’s most commonly observed deficiencies. If you want to avoid these issues and reduce risk you need Equipment Maintenance, Calibration and Cleaning: A Guide to FDA Inspections.