- “We want you to step down from Quality Department and move back into Business Development”
- “I spoke with top medical device manufacturers and they said there will be no FDA audit”
- “Chief Cheese Officer”
Within 3 days of hearing the remarks above from senior management, I was contacted directly by an FDA inspector on Friday afternoon stating that MemoryMD would have 5 days to select a date to begin inspection of our medical device company. Fortunately, I had been preparing myself for some time so after communicating the update to everyone responsible, I begin to mentally prepare myself for the surprise audit by reading, listening, and watching up on every available piece of content covering QSIT FDA inspections.
8 months ago, in November of 2018, myself and our part time quality engineer embarked on a journey to begin building our company’s quality management system.
We first started with developing SOPs as laid out by CFR820 FDA regulation. We had to read, understand, and synthesize the legal and regulatory requirements and design and document appropriate SOPs that would reflect the uniqueness and smallness of our company, as a specification’s developer, while still ensuring that the SOPs met compliance with law codified by Congress and enforced by the Food and Drug Administration.
Next, we had to consolidate all design documentation of our company’s products. This was no easy task as much of the documentation was in Russian, unorganized, and not even in our possession.
It took months of back and forth with our CMOs to get them to provide adequate documents, records, and validation methods as required for maintaining appropriate Design History Files, Device Master Records, and Device History Records.
8 months of such activities prepared myself to effectively navigate the audit providing the inspector with any documents they would need and effectively answering any question they had.
I am proud of myself, at 28 to have successfully completed an FDA audit with only 3 observations being issued that are extremely manageable to develop a corrective action plan against.
Sitting across from an FDA inspector is an extremely stressful event, as you sit there and try to calculate every possible direction the FDA inspector may go. My words, thought process, and responses would toe the line between presenting the company as a competent manufacture or a disorganized company with no controls in place to successfully operate in the US healthcare system.
We must respond with the corrective action plan within 15 business days. But today, I enjoy the new found milestone.
