For some pharma companies, a 483 from the FDA is the result of an ailing organization, not just a plant with a few problems. We think it could be an opportunity to emerge better, stronger, and more competitive.
Just recently, a potential drug shortage affected children with leukemia. A voluntary halt in production at a plant due to quality concerns meant the drug would be in short supply — a drug that could mean the difference between life and death.
The shortage lessened as other companies stepped in to produce more of the drug, but the situation highlights the need for pharmaceutical enterprises to evaluate if they are also at risk.
Adversity as a launch pad
The plant shutdown came after the Federal Drug Administration had cited the company following inspections, pointing out problems on a FDA 483.
Our consultants have worked with other pharmaceutical companies that faced similar findings, as they operated under warnings from a 483 and the even more severe warning letters and consent decree. In fact, our consultancy has extensive experience managing 483, warning letters, and consent decrees to effect the non-technical aspect of the transformation in quality needed to permanently—and quickly—turn these around.
We understand the stress and dismay that kind of scrutiny can cause, but rather than cause despair, such situations offer a powerful crossroads for companies as they pursue improvements. As one client says, “[You] helped us rapidly and effectively respond to current regulatory challenges while proactively designing our company for the future.”
Reopen 60% faster
In a letter to the affected pharmaceutical company, my colleague, Insigniam management consultant June Zeringue writes, “Our clients have found that the work became a launch pad in building an inspiring future for their company.”
She notes that one Fortune 500 company under a consent decree met recertification requirements to reopen a plant 60% faster than it had predicted it could after collaborating with Insigniam. The company also achieved these Breakthrough Results:
- met financial goals for the first time in five years.
- enhanced management and employee satisfaction and morale.
- prevented employee burnout by alleviating former command-and-control tactics.
- met recertification in a sustainable manner.
- minimized waste.
- reduced batch card errors.
- improved employee well-being.
- established a new quality culture that spread to the global network of plants.
Rather than retreat, the company moved forward boldly. Use the adversity as a chance to propel your enterprise to the next level. Look at it as more than a chance to regroup. Consider it a chance to reinvent.
You may end up with better processes, supply chain management, cross-functional collaboration, employee morale, and more. Being shown your weaknesses can sometimes make you stronger.
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