A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests.
The recall is the latest sterility-related incident to hound the compounding industry and the fourth sterility-related recall by a compounder in the past month. Since January, sterility concerns have triggered 19 warning letters and a slew of 483s for the compounding industry.
Downing Labs launched the recall less than two weeks after a Sept. 14 to Oct. 9 inspection of its Farmers Branch, Texas, facility found investigations weren’t conducted or were inadequate in 22 cases of contamination or out-of-specification results.
Investigators also found evidence of spore forming bacteria in a clean room area and use of nonsterile disinfectants, according to a Form 483 issued by the FDA’s Dallas district office.
The recall affects only sterile products distributed nationwide and in the UK between April 20 and Sept. 15. No adverse events have been reported, the company said.
The recent inspection was not Downing’s first run-in with the FDA. In September 2014, the compounder refused the agency’s request to recall 22 lots of sterile drugs after contamination was found during a June 3 to July 16, 2014, inspection that also resulted in a 483.
Observations from this year’s inspection — poor contamination prevention procedures, failure to test batches to ensure they’re pyrogen-free, lack of a written stability testing procedures and lack of written production and process control procedures — were all repeats of violations in the 2014 inspection.
In 2013, the compounder, operating under the name NuVision Pharmacy, also refused an FDA request to recall its sterile products. Ashley Downing, former director of NuVision, subsequently purchased the firm and renamed it Downing Labs.
Last week, the FDA warned against using sterile products from an Oklahoma compounder after it refused to stop making sterile drugs following a failed inspection, and earlier this month, a California compounder refused to recall its sterile drugs. Those incidents followed the September recall of an Alabama compounder’s entire product line due to sterility issues.
Downing said that her firm requested the latest inspection as part of registering as an outsourcing facility and ensuring compliance with the FDA’s 503B requirements. The compounder is in the process of responding to the 483 and is making operational changes to address the observations, she added.
To view the Form 483, go to www.fdanews.com/10-22-15-Downing483.pdf . — Kellen Owings