Quality System Inspections of Foreign Plants Up Sharply in 2012: FDA

May 30, 2014

Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Overall QS inspections were up 37 percent for the year.

The number of warning letters also rose that year, due to “an increase in inspections, increased focus on foreign firms by the foreign device cadre and improved site selection,” the agency says. However, there were fewer “official action indicated” inspections that resulted in untitled letters because of missed FDA deadlines or insufficient evidence.

Foreign companies accounted for 300 — or 10 percent — of the FDA’s 2,748 QS inspections in 2012. They also accounted for 62 (32 percent) of the 195 OAI outcomes and 66 (40 percent) of the 164 warning letters.

Corrective and preventive action issues, along with inadequate production and process controls, topped the quality violations FDA investigators found in 2012. Both observations were noted in 30 percent of Form 483s.

Other frequent observations related to quality audits and complaint files, specifically establishing and maintaining procedures for receiving, reviewing and evaluating complaints. Additionally, “the number of observations related to … device history record increased significantly in 2012,” the FDA says.

For warning letters, problems with CAPA procedures and complaint files were the most frequent citations. The agency notes two violations that were cited at higher rates in warning letters than in inspectional observations:

  • 51 letters included a design history documentation violation; and

  • 49 letters included a process validation violation.

Of 164 warning letters with QS citations, 32 percent included CAPA citations, 30 percent cited production and process controls, 16 percent cited design controls, 12 percent involved documentation controls and 10 percent cited management controls.

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