Drugs

Multiple Violations at Family Pharmacy of Statesville

A 2/3-2/12 FDA inspection at Family Pharmacy of Statesville, Statesville, NC, found multiple drug compounding violations. An 11/6 Warning Letter discusses violations relating to compounded drug products under the Federal Food, Drug, and Cosmetics Act, failing to meet the conditions of Section 503A, adulterated drug products, and misbranded drug products. The letter lists these Current Good Manufacturing Practice violations:

failing to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failing to adequately design the facility with adequate separation or defined areas or such other control systems necessary to prevent contamination or mix-ups;
failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
failing to use appropriate air filtration systems for production areas.

While some of the firm’s responses relating to insanitary conditions appear to be adequate, the letter says, the adequacy of other responses could not be determined because the pharmacy did not include sufficient information or supporting documentation. The response also did not address an observation about compounding drug products without a valid prescription for individually identified patients, FDA says.

The agency recommends that Family “undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.”

The pharmacy was told to respond with a list of specific steps being taken to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completing the work.

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