The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Becton Dickinson Caribe Gets Form 483 for Poor Procedures

Jan. 20, 2017

Becton Dickinson Caribe received a Form 483 for its corrective and preventive action (CAPA), device acceptance, and process validation procedures.

The FDA inspected Becton’s Juncos, Puerto Rico, facility and reported that CAPA procedures were not adequately established. CAPA actions implemented in response to confirmed product failures and for which root causes had been attributed to the manufacturing process did not extend to all impacted products, including products distributed before the corrective actions were implemented.

For example, a situation analysis was initiated as a result of an increased frequency of complaints regarding blood leakage, blood splatter, inadequate tube filling, and other problems with the BD Vacutainer Blood Transfer Devices. Device samples subsequently failed the acceptance criteria for leak testing, but no corrective actions were implemented for some affected products.

Inspectors also said Becton failed to adequately establish device acceptance procedures. In particular, test methods used to challenge for required product specifications were not properly validated, and acceptance activities to challenge for device specifications were not able to measure for the required range of products specifications.

Lastly, the Form 483 said Becton failed to prevent the release of products during the execution of process validation activities when changes to process parameters were being validated to prevent the recurrence of reported failures, or when a validation exercise did not comply with required acceptance criteria.

This management report, Effective 483 Responses: Focus on CAPA Violations, will provide appropriate responses to CAPA violations within the 15-day time frame. If your company hasn’t received a 483 with CAPA observations, you can match your systems with those that have and ensure that all gaps are closed before your next inspection. Stay up-to-date and ace the inspection.

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