Facility closure and restart for contract manufacturing operation
"Mary was instrumental in developing the Corrective Action Plan that met the needs of the FDA, the consultants and our customers. She utilized great logic, skill and legal acumen in merging the needs of all critical stakeholders so that our plan was both effective and efficient. In addition, she showed concern and empathy for the site team and myself during this difficult time.Â
I certainly give Mary my highest recommendation."
Rich Appeldoorn, Site Head
Challenge
Following a difficult FDA inspection and a 483 that revealed several critical findings, the company received a Warning Letter and voluntarily suspended operations at a key contract manufacturing facility. With my engineering background, I was asked to provide law support to the site.
The root of the problem was this once state-the-art facility had been eclipsed by constantly evolving cGMP requirements. Because many things registered as exceptions, staff had become unable to distinguish real issues from an excess of routine deviations.
Solutions
We began by handling recalls and third party contractual matters related to supply interruption. We also engaged external GMP experts to address the deficiencies.
Liaising between the experts and management, I helped the site head thread the needle between our consultants’ aspirational improvement suggestions, and what the facility could realistically accomplish. Together we came up with a thoughtful corrective action plan that satisfied FDA. Staff needed extensive retraining.
Results
Through effective collaboration, the site head and I navigated thorny regulatory and human elements, fostered a stronger compliance culture and enabled a successful restart six weeks later, turning adversity into positive change.