FDA EIR - AndersonBrecon Inc. - September 04, 2019

An FDA surveillance inspection of AndersonBrecon Inc (dba PCI Pharma Services) in Rockford, IL, was conducted on September 4, 2019. The inspection, guided by Compliance Program 7382.845 and the QSIT Manual for medical device manufacturers, focused on Corrective and Preventive Actions (CAPA), Management Controls, and Production & Process Controls for Class I and II medical devices. While no FDA Form 483 was issued, two significant observations were discussed with management. The first concerned inaccurate documentation within a CAPA record (AI-5517). An effectiveness check wrongly indicated a recurring issue with the same root cause had not repeated, despite internal documentation showing two such instances. This implicated non-compliance with regulatory requirements for CAPA documentation. The second observation highlighted that the company's quality policy and objectives were not formally established or approved by management with executive responsibility, nor were local quality documents fully aligned with corporate commitments. In response, AndersonBrecon Inc. committed to providing a written response. Management promised to correct the specific CAPA record, implement a global correction for similar documentation issues, ensure thorough quality reviews for all future CAPA closures, and formally establish an executive-approved quality policy, aligning it across the organization with corresponding employee training. The firm also addressed Unique Device Identification (UDI) compliance with a contracting party.