Q: Does every complaint require some kind of complaint investigation? A: Yes, but with some qualifications. For each complaint you receive, you should determine the extent of the problem, its impact (risk) to the user, patient or by-stander, and its validity. Why…
Tag Archive for Complaints
ER Analogy: When to See the CAPA “Specialist”
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Q: My company continues to struggle with deciding when to elevate a complaint to the level of a CAPA. And at times we disagree about how to differentiate complaints, non-conformances, and CAPAs. Can you help us sort it all out? A:…
CAPA Data Sources; What Makes a Compliant CAPA System
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Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? Moreover, what are…
Internal Audits: Are They Really Necessary?
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Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…
When Should You Open a CAPA Based on a Non-Conformance Report?
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Q: At my company, a non-conformance report (NCR) is initiated for a product non-conformance that is created and found internally. Would you automatically elevate the NCR to a corrective action request? In other words, with the exception of issues you decide…
Medical Device Reporting (MDR) Rules: Do They Apply If You Only Manufacture (and Not Sell) Devices in the U.S.?
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Q: We’re planning a new venture to manufacture medical devices in the U.S. but export them only. There will be no commercial distribution in the U.S. and no marketing clearance in the U.S. I understand that for other manufacturers with 510(k)…
Does Use Error Count as a Reportable Event?
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Q: To what extent is a manufacturer responsible for filing a Medical Device Report (MDR) when a lack of training affects a patient, or when a complaint has not been sent to the manufacturer? For example, if we found that a…
Complaint Investigations: Are They Required When Products Are Used Off-Label?
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Q: Does FDA require complaint investigations for a “lack of effect” when there is an off-label use of the product? Or, can we log the report into our complaint investigations system for tracking purposes, then close the report with a note…
Management Reviews: A Checklist for Compliance
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An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…
Checklist for Complaint Handling Procedures
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Proper management and follow-up of product complaints is one of the major stumbling blocks for FDA-regulated companies. Compare your existing Complaint Handling Procedures against this checklist of best practices: √ Define your complaint sources √ Decide how a complaint is…