Inspectors cite Halvard & Pike Apothecary of Portland, Maine over sterility assurance

Inspectors have cited Halvard & Pike Apothecary of Portland, Maine over sterility assurance at its sterile-preparation suite, according to an inspection report reviewed by the Journal. The observations include an inadequate media-fill programme, environmental monitoring excursions closed without investigation, and a quality unit whose reporting line ran to the production manager rather than independently.

The observations, in the order the report lists them: media fills not performed at the required frequency; smoke studies not repeated after a change to the airflow configuration; 4 environmental monitoring excursions closed without a documented investigation; personnel gowning qualification records incomplete for two operators; and a quality unit lacking independent authority to reject a batch.

Enforcement in this sector is slow by design: inspection, observation, response, escalation, letter, and only then injunction or decree. The consequence is that a facility with a serious quality problem can continue operating for a year or more while the process runs, and that the closure, when it comes, appears sudden to everyone outside it.

"A batch range instead of a lot list is a decision," said Dr Hilde Bruinsma, hospital pharmacist, Groningen. "It is cheaper for the company and it transfers the work to every pharmacist holding stock."

"The recall notice is written for a distributor and read by a pharmacist," said Dr Rafał Sikorski, toxicologist, Medical University of Warsaw. "A batch range instead of a lot list transfers an afternoon of work to every one of them."

This action has been added to the Journal’s running index of compounding-related enforcement, which records the date of inspection, the observations, the response and the outcome for every action we have been able to document.