Compounder Hit with Warning Letter Over Sterility, Labeling and Reporting Deficiencies

August 12, 2016

A Mississippi compounder received an FDA warning over a multitude of GMP issues at one of its facilities.

An inspection conducted at Coastal Meds’ facility in Biloxi uncovered “serious deficiencies” in the company’s production of sterile drug products, leading to six citations.

One example was an inspector witnessing an employee’s clothing brush across the tops of open vials of drugs, potentially contaminating the contents. In a cleanroom, an inspector saw another employee produce sterile compounds without appropriate protective gear.

The remaining GMP violations concerned quality assurance. The warning letter notes that the facility neglected to establish appropriate systems for monitoring environmental conditions in its aseptic processing areas, for cleaning and disinfecting rooms and for cleaning equipment to ensure sterility.

The labels of the facility’s products also drew concerns from agency inspectors. According to the warning letter, the drug products contained shoddy labels that omitted statements such as, “This is a compounded drug.”  The product labels, additionally, failed to bear appropriate directions for their intended use, thereby rendering them misbranded.

Investigators lastly cited the facility for not having FDA-approved applications on file for its drug products and not reporting drug products that it compounded to the FDA after registering as an outsourcing facility in December 2014 and again in June 2015.

In response to the allegations, the facility took corrective measures that the agency deemed largely adequate.  The FDA is asking the company to provide additional information on the facility’s smoke study and on interim actions to ensure quality. It’s also recommending the facility undertake a comprehensive assessment of its operations as well.

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.

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