US Food and Drug Administration issues warning letters to drug manufacturers for manufacturing violations

The US Food and Drug Administration has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices and laboratory requirements, according to RAPS. The specific issues include concerns about ensuring that final products are sterile and meet purity and strength specifications. Jiangmen Shuizirun Sanitary Articles in China and Hanlim Pharm in the Republic of Korea both received letters outlining several manufacturing violations, including failing to ensure their products were manufactured under sterile conditions. Jiangmen produces products labeled as sterile, but investigators said their over-the-counter products are not produced in accordance with agency requirements. Hanlim was cited for failing to establish and follow written procedures to prevent microbiological contamination of drug products that claim to be sterile. Investigators found that products were being manufactured using poor aseptic practices, and smoke studies showed that airflow patterns failed to protect the processing line. Drug compounder SCA Pharmaceuticals in Arkansas also received a warning letter for manufacturing, packing, and storing sterile products in insanitary conditions. The facility lacked routine certification for ISO 5 areas and failed to take corrective action after microbial contamination was discovered. Wisconsin-based Eurofins SF Analytical Laboratories and Virginia-based Silgan Dispensing Systems were among the companies that failed to ensure their final product met specifications. The agency said Eurofins' quality unit lacked adequate oversight and control over its laboratory operations. Silgan's quality unit was similarly admonished for failing to adequately oversee production and failing to validate supplier test analyses. Executive management at these firms must immediately and comprehensively assess global manufacturing operations to ensure systems conform to requirements. For your business, check your supplier compliance before placing new orders to avoid unexpected product holds or supply shortages.