FDA Finds Compounders Embroiled in Sterility Issues

November 19, 2015

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.

To deal with the increased sterility problems, the FDA recently issued final guidance on enforcement actions it will take against compounders.

Downing Labs launched the recall less than two weeks after a Sept. 14 to Oct. 9 inspection of its Farmers Branch, Texas, facility yielded findings that 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, according to a Form 483.

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 2014 inspection.

Observations from this year’s inspection — poor contamination-prevention procedures, failure to test batches, lack of 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 company and renamed it Downing Labs.

Downing said that her company 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.

Park Ceases Sterile Operations

The FDA issued a safety alert for Park Compounding Pharmacy in Westlake Village, Calif., following an Aug. 31 to Sept. 11 inspection that uncovered sterility deficiencies in the firm’s aseptic processes.

In the notice, the FDA recommended that Park cease sterile operations and recall all of its non-expired sterile drug products until corrective actions are made. The company agreed to cease sterile operations but refused to recall its products.

The 10-item Form 483 lists numerous problems related to the company’s aseptic processing areas, including insufficient separation of nonsterile and sterile products to prevent contamination, insufficient stability testing, inadequate container closure systems and uncalibrated laboratory equipment.

Park Compounding did not return calls for comment.

Specialty Medicine Surrenders License

Despite having been closed for more than a year with no plan to reopen, the FDA issued a warning letter to Specialty Medicine Compounding Pharmacy for a litany of cGMP violations, including poor sterile processing controls.

During an Oct. 21 to Nov. 5, 2013, inspection, the firm was cited for failing to validate all sterilization processes, failing to ensure workers wear protective clothing and failing to sterilize equipment and utensils to prevent contamination, the warning letter says.

The FDA initiated the inspection two days after Specialty Medicine launched a massive voluntary recall of 79 different sterile drug products.

On Oct. 29, 2013, the company voluntarily surrendered its pharmacy license, shuttering its operations in April 2014.

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