Seven Compounders in Trouble With FDA for Poor Sterile Practices
Last month, the FDA zapped seven more compounders in Tennessee, California, Florida, Arkansas, Montana and Washington over sterility issues. The FDA handed out three warning letters, three Form 483s and one facility issued a recall following an inspection.
The spate of warning letters marks the 19th the agency has issued this year for poor sterile practices at compounding facilities.
The warning letters and Form 483s continue a trend that John Voliva, director of legislative relations at the Professional Compounding Centers of America, says his group is trying to address.
Compounders need to perform sterility testing on a regular basis and make sure they are adhering to the FDA’s cGMP regulations, which differ from the U.S. Pharmacopeia 797 standards for compounding that most of them focus on, Voliva said. PCCA also encourages its members to perform gap analyses between the two standards to identify any shortcomings.
One issue that concerns PCCA is the long gap between inspection, Form 483, a firm’s response and the warning letter, Voliva adds. The letters come almost a year after the inspection, and that needs to be changed.
Warning Letters Keep Coming
During inspections of Newport Beach-based California Pharmacy & Compounding Center conducted last year, investigators noted that sterile production occurred during two separate three-month timeframes, but the firm didn’t conduct any environmental monitoring during those periods. Investigators also observed operators compounding sterile drugs without protective clothing, the June 17 warning letter says.
A spokesman for California Pharmacy said the firm is working to remedy the observations.
In a July 16 warning letter, the FDA faulted Boca Raton, Fla.-based KRS Global Biotechnology for failing to monitor the air and condition of its clean room on a daily basis. Investigators from the agency’s Florida district office observed operators manually stoppering vials with their gloved hands. They also cited KRS for not having defined areas or other controls to prevent contamination or mix-ups.
During the March 4 to March 17, 2014, inspection, labels on some drugs were missing the date of compounding, storage and handling instructions and a statement saying they were compounded drugs. Some products also failed to list active ingredients or information on adverse event reporting. KRS did not return a request for comment by press time.
More Sterility Failures
In a June 25 warning letter, the FDA rapped Little Rock, Ark.-based SCA Pharmaceuticals for failing to investigate sterility failures, batches containing particulates and daily pressure differentials that were out-of-specification. Investigators from the Dallas district office also dinged the firm for not monitoring its clean room areas and testing sterile drugs for endotoxins.
Like KRS, SCA failed to ensure that all product labels included information on adverse event report and other required information statements.
SCA’s President and CEO Gene Graves said his firm hadn’t heard from the FDA following its April 2014 response to a Form 483, and has not had an inspection since then. The company believes it satisfied the FDA’s observations and made other significant quality improvements in the subsequent 15 months.
The FDA urged the compounders to conduct a comprehensive review of their operations and to hire outside consultants with sterile drug manufacturing expertise to bring their shops into compliance.
Meanwhile, The Compounding Pharmacy of America, based in Knoxville, Tenn., received a 16-observation Form 483 following a May 12 to 21, 2015, inspection for lack of sterile controls and not testing products to ensure their sterility. Systems for cleaning and monitoring aseptic processing areas also were deficient, and the firm didn’t have a quality control unit, the 483 says. The Compounding Pharmacy of America did not respond to a request for comment by press time.
The FDA also slapped The Wellness Center Pharmacy of Chattanooga, Tenn., with a 13-observation Form 483, following a May 18 to 28 inspection. Investigators observed employees in clean rooms with inadequate protection and no validation of procedures for preventing contamination. The Wellness Center Pharmacy did not respond to a request for comment.
Montana Compounding Pharmacy and Wellness Center was also hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. During an April 28 to May 8 inspection, investigators found the firm did not conduct microbiological tests of each lot of drug components and had no procedures to prevent contamination of sterile drugs. Employees reused sterile protective apparel or did not wear any.
The compounder also lacked procedures for assessing a drug’s stability, receiving components and container closure systems used for producing sterile drugs, and complaint handling. Montana Compounding Pharmacy and Wellness Center declined to comment.
Washington Compounder Recalls 95 Drugs
Moses Lake Professional Pharmacy is recalling 95 different compounded drugs following an FDA inspection that identified a problem with sterility assurance. The products were made from July 21, 2014, through July 21, 2015, and include hormonal contraception drugs and vitamin injectables. Moses Lake did not return a request for comment by press time.
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