FDA Warns Compounders for Poor Aseptic Processing Practices, GMP Violations

The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products.

The agency released warning letters to Wells Pharmacy Network in Wellington, Fla., and Eastern Pharmacy in Ocala, Fla. Both compounders were chided for poor aseptic processing practices and not following agency GMPs.

Wells’ warning letter stems from three separate agency inspections dating back to July 2013. During each inspection, the agency found Wells was compounding drugs without a prescription, violating the 2013 Drug Quality and Security Act (DQSA).

Investigators also discovered problems with how the drugs were compounded. Wells didn’t establish a stability testing program and failed to ensure its compounding personnel wore adequate clothing to protect drugs from contamination. The pharmacy also didn’t have an adequate system for cleaning and disinfecting the room used for aseptic operations and failed to establish an adequate system for monitoring environmental conditions.

Each of the FDA’s visits resulted in a Form 483 for Wells, according to the Nov. 10 letter. The pharmacy responded to each 483 by saying that it follows U.S. Pharmacopeia (USP) guidelines for sterile compounding.

The FDA noted, however, that since Wells is making drugs without a prescription, it needs to meet good manufacturing practices, which have stricter regulations for aseptic processing than USP.

Eastern Pharmacy also was chided for poor quality. The FDA inspected the company’s facility in January 2014 after receiving adverse event reports from at least 37 patients who took repackaged intravitreal injections of Genentech’s Avastin (bevacizumab) and Lucentis (ranibizumab).

The pharmacy repackaged units of Avastin and Lucentis by completely removing the rubber stoppers from the sterile vials, the FDA said. This exposed the drugs to considerable risk of microbial contamination.

Eastern also had no door or closure installed to separate the aseptic processing area from the common pharmacy area. While Eastern had a laminar flow hood, which is used to handle materials in a cleanroom, the company admitted that the hood was not functional, and only used because “it was a flat surface,” according the Oct. 29 warning letter.

The compounder told the FDA that it has ceased production of sterile drugs. The FDA warned that if Eastern ever decides to resume production it will need to conduct a sweeping assessment of its quality system.

Since passage of the DQSA in November 2013, which boosted agency powers over large compounders, the FDA has not shied away from warning pharmacies for poor quality or for not following GMPs. The agency so far has issued 26 warning letters to compounders this year.

Eastern Pharmacy declined to comment. Wells Pharmacy did not return a request for comment as of press time.

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