FDA Seeks Drastic Action from GSK Subsidiary on Penicillin Contamination

The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or restrict production to penicillin.

The agency asked SmithKline Beecham “to commit” to one of those options at its Worthing plant after penicillin was found in non-penicillin production areas of the plant 187 times between 2012 and 2015, according to a warning letter.

FDA inspectors chalked this up to “significant deviations” in the company’s procedures to prevent cross-contamination, investigate critical deviations and implement corrective and preventive actions for active pharmaceutical ingredients.

The letter also cautions the company against shipping any non-penicillin drugs produced at the facility “until the FDA determines that your proposed decontamination plan, methods and procedures are adequate, comprehensively implemented, and verified via an FDA inspection.”

While the company responded to the allegations prior to the warning letter by acknowledging the issues with its analytic method and validation techniques, the agency deemed the response inadequate. More to the point, the agency said the company did not supply any supporting data or justification for its validation process.

The warning letter also faulted the company for potential microbial contamination. Agency officials accused the company of failing to investigate and establish root causes for microbial contamination, citing 25 breaches from April 2014 to February 2015.

All of the complaints stem from a July 2015 inspection of the facility.

GenPak Solutions

Another manufacturer was faulted for GMP issues after an FDA inspection uncovered serious violations at its repackaging facility in Ohio.

The warning letter accuses GenPak Solutions of distributing an unapproved new drug, misbranding products, failing to properly clean equipment, neglecting to follow adequate written testing programs and failing to check production records properly, among other complaints.

Chief among the agency’s complaints was the company’s repackaging, relabeling and distribution of the AnodyneRx medicated patch. The FDA said the product meets the legal definition of a prescription drug but was never approved by the agency.

On a related note, the letter complained that the product lacked adequate directions for use, rendering it misbranded. The agency claimed that nearly 100 different drug products produced at the facility were misbranded in one fashion or another.

While the company responded to the complaints prior to receiving the letter, the agency dismissed GenPak’s proposed corrections. The FDA asserted that the company needs to provide documentation on its cleaning and repacking process, stability testing program, and validation protocols and reports.

The allegations were prompted by an August 2015 inspection of the facility.

Earlier this year, the FDA issued final guidance on Applying Human Factors and Usability Engineering to Medical Devices, shedding light on the factors that companies should consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use.

Order our webinar ISO 13485: What’s New and How It Affects You to learn more about the ins and outs of the new, revised ISO 13485 standard.