FDA EIR - Sterling Medical Products Intl, Inc. - August 10, 2018

An FDA inspection of Sterling Medical Products Intl, Inc., a company engaged in repacking, relabeling, assembling, sterilizing, and distributing Class I and Class II medical devices and pharmaceuticals, was conducted from August 9-10, 2018. This routine inspection, guided by the Quality Systems Inspection Technique (QSIT) Manual and Compliance Program 7382.845, aimed to assess the firm's quality system, including corrective and preventive actions (CAPA), production and process controls, sterilization validation, and recall processes. While no FDA Form 483 was issued, the inspection identified nine less significant observations discussed with management. Key issues included inconsistent use of Medical Device Report (MDR) forms and terminology, insufficient detail in complaint reports, and inadequate record retention practices (destroying records after five years, violating 21 CFR 820.180). Furthermore, the firm was not consistently utilizing its CAPA forms or identifying data sources on them, and internal quality audits lacked independence. Other concerns involved undocumented lot coding procedures, infrequent supplier evaluations, and incomplete documentation for recalled device destruction. It was also noted that the company's FDA registration did not reflect its handling of Class II devices or its pharmaceutical sterilization and distribution activities, despite having a state license for wholesale drug distribution. The company's Plant Manager voluntarily committed to addressing all identified deficiencies, including correcting internal terminology, improving documentation for complaints, CAPA, and recall destruction, revising record retention policies, ensuring audit independence, and updating registration to reflect all regulated activities.