Kansas Compounder Dinged for GMP Violations, Unapproved Ingredients
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved.
According to the Feb. 3 warning letter, Perry Drug failed to adequately follow cleanroom procedures when making sterile drugs. An employee wearing makeup was observed processing sterile drugs with nonsterile gloves.
The FDA also chided the compounder for not having a system to monitor pressure differentials throughout the day, especially during periods of production, and for not demonstrating that its hoods protect sterile products from contamination.
Investigators from the FDA’s Kansas City office further called the company out for making drugs containing domperidone, which is not part of an FDA-approved human drug and not on a list of bulk drug substances that may be used for compounding.
The letter stems from an Aug. 26 to 29 inspection at Perry’s Overland Park facility, which prompted a voluntarily recall of sterile drugs produced between Oct. 4 and Nov. 3 of last year. The firm stopped compounding sterile drugs on Nov. 4.
The letter notes that the firm responded to a September Form 483 by notifying the FDA that it is no longer dispensing compounded drugs that aren’t produced in response to a prescription and that it will adhere to state law and USP guidelines for compounding sterile and nonsterile drugs.
Karla Palmer, an attorney with Hyman, Phelps & McNamara, which represents Perry Drug, says the company has responded to the warning letter and is addressing the agency’s concerns.
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