Facility operations compliance assessment
Expanding medical device supplier avoids FDA penalty while preventing facility closure.
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The client
An industry leading medical device company feared FDA investigation after acquisition of a new facility. The acquisition expanded the supplier’s manufacturing and selling capabilities.The challenge
The supplier was in the process of acquiring a third-party manufacturer to increase its product line, however accusations of poor quality threatened a pending FDA investigation. After conducting internal audits and quality inspections, management identified observations that, from a forward-thinking strategy, could be viewed as a potential regulatory violation of the FDA.The solution
The supplier turned to our medical device specialists to perform a compliance assessment of the facility’s operation and identify elements that threatened noncompliance. Our medical device experts quickly provided a report that identified all elements that were noncompliant or could have been noncompliant in an imminent FDA inspection. The team provided a remediation plan to identify these resources and apply them against a timeline to fix each individual element. This resulted in increased productivity and a 100 percent compliant facility, meeting both regulatory quality and customer requirements.
The benefit
Our medical device team’s knowledge and experience resulted in several benefits to the medical device supplier, including:
- A successful FDA audit that resulted in zero observations and no 483 report issuance.
- Prevented closure of the newly acquired facility, saving jobs and further product transfer costs.
- Our product transfer team was originally contracted to help shut down the facility and move all products to a compliant third-party location. However, upon solving the compliance issues, we determined the best long-term solution for the supplier was to maintain production at the current facility. We placed the suppliers’ best interests above our own.
- Increased product production and plant capacity — the production facility now enjoys 100 percent regulatory and customer compliance.
