Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality…
Tag Archive for 483 Observation
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches
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Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days? A: Supplier management — how carefully…
What FDA Inspectors are Trained to Look For…
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To effectively prepare for a visit from FDA, you must learn to look at your operations through the eyes of an FDA inspector. For your computerized systems, some items FDA inspectors and investigators are trained to observe include: – Is…
How Often Should You Conduct Internal Audits?
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Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…
Quality Data: Are FDA Investigators Trained to Analyze Various Data Sources?
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Q: Are FDA investigators trained to analyze various quality data sources to help them identify other areas to audit? At my company, it’s common that an individual department will track and trend quality data metrics within its own area and…
FDA 483 Observations: Should You Provide Copies to Clients?
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Q: We’re a testing lab, and I’m completing a routine Quality Survey for one of our clients. They asked if we have received any FDA 483 observations from FDA inspectors and, if so, they would like a copy. Should we freely…
FDA 483 Observations: 8 Best Practices for Responding to FDA Inspections
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Legally, you don’t have to respond to FDA 483 observations. But practically, you should; it’s in your best interest to respond quickly and in writing. A well prepared 483 response demonstrates to FDA and other stakeholders that you understand the…
483 Response: What to Include in Your Letter to FDA
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Q: When we prepare a 483 response letter to an FDA notice of inspectional observations, do you recommend we include supporting documents such as SOPs and training records — even those we’ve already shared with the on-site FDA inspector?A: Yes, and here’s the…
Managing FDA Inspections: Do’s and Don’ts
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When FDA is at your site, follow these suggestions for managing FDA inspections — offered by the EduQuest staff, many of whom are former FDA expert field investigators: Have a defined location for investigators to work. Always accompany them through your facility.…