FDA Continues to Zero in on Compounders

The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted two pharmacies in Florida in recent warning letters.

The FDA told Orlando-based Olympia Compounding Pharmacy in a Feb. 4 warning letter that management needs to review facility design, procedures, personnel, processes, materials and systems, paying particular attention to aseptic processing.

The letter cites a November 2014 inspection during which employees were seen processing sterile drug products in a laminar flow hood that was not turned on and passing materials over open vials.

Olympia Pharmacy has “a history of poor sterile practices,” the FDA notes. In March 2013, an inspection found problems that led to a warning letter and a recall of all sterile products produced before March 27, 2013. The 2014 inspection found that “only limited improvements had been made.”

It also uncovered a variety of GMP violations, including:

• A lack of adequate maintenance systems for the equipment that controls aseptic conditions;
• A lack of appropriate procedures to prevent microbiological contamination of sterile drug products — a repeat violation from 2013;
• A lack of adequate facility design to prevent contamination or mix-ups; and
• Failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas — a repeat violation from 2013.

Olympia did not respond to a request for comment. For its part, the FDA says in the letter to Olympia that it plans to issue “more specific cGMP regulations for outsourcing facilities.” The agency issued final guidance in August 2015 that clarified that compounders should register as outsourcing facilities only if all of their products are compounded according to FDA conditions and comply with good manufacturing practices.

Forearm Exposure

A December 2014 inspection at Myerlee Pharmacy in Fort Myers, Fla. yielded similar observations, according to a Feb. 3 warning letter. The investigator noted an operator with exposed forearms, as well as operators resting their forearms inside laminar flow hoods during aseptic processing of sterile drug products. In addition, personnel did not sanitize certain component bags before placing them inside clean areas.

The investigator also found Myerlee was not receiving valid prescriptions for individually identified patients for a portion of its drug products and was producing domperidone drug products, which are not entitled to the GMP exemptions in section 503A of the FD&C.

The inspection also uncovered numerous shortcomings, including:

• A lack of written procedures to prevent microbiological contamination of sterile drug products;
• A lack of an adequate system for monitoring environmental conditions in aseptic processing areas;
• A lack of an adequate system for cleaning and disinfecting rooms and equipment to produce aseptic conditions; and
• Failure to ensure that manufacturing personnel wear clothing that protects drug products from contamination.

Jeff Steele, pharmacy manager and co-owner of Myerlee, contends that all of the observations were corrected more than 12 months ago and that the facility was incorrectly inspected as a 503B pharmacy when it is actually a 503A. He notes that the inspector said these types of inspections are “brand new” for the agency.

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