The QMN Weekly Bulletin

“No formal quality policy on hand.” That’s what FDA field investigators wrote in a Form 483 report after inspecting Precision Systems’ Natick, Mass., plant in May 2011.

The FDA may soon issue agency-wide guidance to clarify drug and device manufacturers ’ responsibilities for the quality of ingredients manufactured by contractors, agency officials say.

Gulf Medical Fiberoptics failed to establish and maintain adequate procedures for validating the design of its fiber optic cables, according to a Form 483 FDA investigators wrote after a follow-up inspection in 2010.

A principal investigator who confessed to disregarding her trial responsibilities received an FDA warning for “systemic failures” in trial conduct that include failing to personally execute or adequately oversee two trials, as well as protocol deviations.

The FDA has warned Midmark after the devicemaker failed to strengthen corrective and preventive action (CAPA) procedures at its Versailles, Ohio, facility as the agency urged in an earlier Form 483.

The FDA warned Akzo Nobel Chemicals’ Mexican manufacturing facility and placed the plant under an import alert after it failed to investigate and prevent shipment of contaminated products.

The Global Harmonization Task Force’s (GHTF) Study Group 2 recommends a three-tiered classification system for field corrective actions (FCAs), according to draft guidance.

Drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, are urged to perform risk assessments and take preventive action, the FDA says.