What To Know About Inadequate Training of Personnel In Relevant Procedures Or Quality Control Measures
We have been reviewing the most common FDA 483 violations in the last five years. Another common 483 violation is inadequate training of personnel in relevant procedures or quality control measures – 21 CFR 211.25(a) Personnel Qualifications and Personnel. FDA records state there have been 55 FDA 483 violations for inadequate employee training since 2021. […]
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…And the Top FDA Drug 483 Observation Is……
We reviewed FDA’s FY 2024 inspection list for drug companies last week. FDA performed 561 cGMP inspections of drug companies last year. California had the most cGMP inspections, followed by Texas. That got us wondering what the most common FDA 483 observation is. According to recent FDA data, the top cGMP citation on FDA 483s […]
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How Often Does FDA Flag CAPA Flaws in 483s and Warning Letters?
FDA recently issued five warning letters to medtech companies for falling short on cGMPs under the QS regulations. The most common issue raised by FDAers were the companies’ failure to implement CAPAs. On Jan. 14, 2025, FDA published five warning letters to Hologic, Integra Lifesciences, Randox Laboratories, Xoran Technologies, and Phillips Precision. The agency found […]
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What Happens When You Mishandle 129,000 Customer Complaints?
Mishandling thousands of customer complaints is always bad. When you make medical devices for the US market, it’s worse. We came across a 2018 FDA 483 for Philips Medical System in Cleveland. The firm was slammed by FDA for inadequate handling of more than 129,000 complaints. FDA investigators visited Philips Medical System in 2017 and […]
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How Inadequate QC Oversight Leads to 483s and Warning Letters
We all know how important robust Quality Control Systems are to the FDA. If so, why are quality system flaws one of the most common FDA 483 citations for years? For example, in 2024, violations of 21 CFR 211.22 Responsibilities of Quality Control Unit led all cGMP citations for the year. Pharmaceutical companies know how […]
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The Day Your Inadequate Quality Control Systems Passed An FDA Audit
A terrible day for a QA manager is to receive an FDA 483 for inadequate quality control (QC) systems. The Code of Federal Regulations (CFR) Title 21, Part 211.22 states requirements for quality control systems in pharmaceutical manufacturing. Violating this important cGMP regulation means bad news for your company. Lack of Independent QC Unit FDA […]
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How to Handle An FDA Warning Letter
Did your company receive an FDA warning letter, possibly including cGMP violations? If so, there are vital steps you can take to reduce the effects of the warning letter. The warning letter will be issued if there is a deficiency or violation in your pharmaceutical or medical device operations. These letters tell you that your […]
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FDA Talks About Importance of Data Integrity And Data Governance Plans
At the recent PDA/FDA Joint Regulatory Conference, CDER’s Quallyna Porte talked about how FDA is focusing on data integrity and data governance plans in 2022 cGMP audits. Porte noted that pharmaceutical companies need a solid data governance plan that is as well established as possible. This ensures across the plant that pharma data is handled […]
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FDA Stresses The Importance Of Engaging With The Agency Early and Formally
In February 2022, FDA organized a public oncologic drugs advisory committee or ODAC meeting to review a sintilimab application that was based on the ORIENT-11 clinical trial done in China only. Instead of following the regular method of reviewing the risks and benefits of one drug, the FDA committee only voted on one question. It […]
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Is Your cGMP Quality System Ready For An FDA Inspection?
At this year’s PDA/FDA conference, FDA’s Director for the Division of International Drug Quality Carmelo Rosa offered the agency’s regulatory point of view on pharmaceutical quality systems. She also detailed some of the latest FDA audit trends of drug facilities. Rosa noted as she reviewed the most frequent FDA warning letter observations for drug manufacturers […]
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