case study

Compliance Assurance Engagement Leads to Passed FDA Inspection and Improved Workflow

The medical device company received an FDA warning letter and sought RCA’s guidance to create a response and remediation strategy. RCA prepared a response and implemented Inspection Readiness Training, resulting in a passed FDA inspection and new best practices.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Compliance Assurance Engagement Leads to Passed FDA Inspection and Improved Workflow

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.

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.

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