Q: Are our quality risk management findings accessible to regulatory agencies? Or are they considered private and confidential company information? A: All quality risk management activities and documentation are accessible to the regulatory authorities. Your company should base its findings on the…
Tag Archive for Complaints
Connect Your Quality Subsystems with Data Links to Strengthen Quality Compliance
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Q: In one of your training classes, you mentioned the importance of establishing data linkages between the various quality subsystems of our overall Quality System. Can you explain further and provide some examples? A: FDA believes these four quality subsystems should be…
Quality System Maintenance: What Activities Does FDA Expect to See?
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Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product. Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a…
Complaint Investigation: When You Don’t Have to Investigate Every Complaint
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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…
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…