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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... Read More »
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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... Read More »
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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,... Read More »
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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... Read More »
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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.... Read More »
