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Compliance Assurance & FDA Inspection
Background
The medical device company received an FDA warning letter and sought Regulatory Compliance Associate® Inc.’s guidance for compliance assurance and remediation strategy. While researching the company’s situation, RCA noticed staff were inexperienced with FDA inspections and could benefit from Inspection Readiness Training.
“RCA not only remediated our warning letter, but they also improved our workforce efficiency and preparedness for agency audits. We didn’t realize what it took to be prepared for an inspection. Prior to RCA, we had cursory reviews by auditors and inspectors, but we always suspected there were issues that weren’t identified. We experienced a thorough inspection when RCA came. Our systems were closely examined by RCA’s mock inspectors, to the point where we really felt like we had been through a real inspection. They identified many deficiencies and areas for process improvement. We now know we are in good shape and are getting better by practicing what we learned. RCA provided great value to us.”
Solution
RCA prepared a response to the FDA and began Inspection Readiness Training throughout the organization. Besides conducting mock inspections, RCA led the company through a compliance assurance process. For example, a planned FDA tour and behavioral training for the staff was conducted. Document review processes, roles and responsibilities were reviewed for both an Inspection Room and Control Room.
Additionally, the compliance assurance process formalized internal procedures and helped prepare staff in answering audit questions. Most importantly, it prepared the internal client team to access documents and provide information to common FDA inspection requests.
Result
The company passed their next FDA inspection with only one minor observation which was easily remediated. The company continued to practice their learnings and will be ready for an inspection, with little or no notice from a regulatory agency.
About RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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