483 Roundup: Devicemakers Cited Over CAPAs, Other Violations
The FDA flagged five devicemakers for a variety of noncompliances observed during inspections, including inadequate CAPA procedures, and failure to properly investigate complaints.
Brit Systems: The FDA issued a Form 483 to Brit Systems in Dallas, Texas following an inspection in late August. The agency said the company’s CAPA procedures were inadequate as they did not include requirements for verifying or validating a corrective or preventative action.
The agency also cited the facility for failing to have written procedures for managing medical device reportable events and for having a complaint handling procedure that did not evaluate MDR complaints.
Azena Medical: The FDA cited Azena Medical’s facility in Walnut Creek, California, following an October inspection. The company failed to properly investigate complaints regarding the possible failure of its product Gemini Soft Tissue Laser to meet specifications. One complaint stated the product’s tips had broken off, and a review of the complaint file revealed there was no documented investigation.
The company was also cited for its design change control procedure, which did not require the validation or verification of design changes before their implementation.
IanTech: IanTech’s Reno, Nevada, facility was cited for failing to set up procedures for controlling and distributing finished devices. Prior to shipping the finished product, the firm failed to establish a quality system that met regulatory requirements.
The firm also had a controlled environment room classified as an ISO Class 8 cleanroom that was used in the manufacturing of a sterile finished device. When asked for qualification records, the firm provided validation result records but could not provide documented proof of validation activities. In addition, the controlled environment room’s qualification result records showed the cleanroom was qualified only after the finished device was manufactured.
The FDA also cited the company for using software in its quality system that had not been validated for its intended use. The firm used the software for document control as well as for SOPs, quality forms, nonconforming material records, CAPA records, complaint records, internal audit records, and other records.
LZR7: LZR7 in Placerville, California, drew a Form 483 following an October inspection, observing its MDR procedures failed to not address numerous issues.
The procedures did not establish a standardized review process for determining when an event should be reported, and did not allow the timely transmission of complete medical device reports to the FDA. The procedures also did not establish internal systems that would allow efficient and effective analysis of events that might be subject to MDR requirements, the agency said.
AccessClosure: The AccessClosure facility in Santa Clara, California received a Form 483 because it did not satisfactorily establish procedures for handling complaints.
After reviewing the firm’s complaint files, inspectors found that the patient, device and event detail information was not adequately collected, and devices were not gathered for examination. No documentation was found indicating that the firm followed up to obtain missing or additional information or issued a device recall that would have aided in the investigation.
Read the Brit Systems Form 483 here: www.fdanews.com/12-06-17-britsystems483.pdf.
Read the Azena Medical Form 483 here: www.fdanews.com/12-06-17-azenamedicalllc483.pdf.
Read the IanTech Form 483 here: www.fdanews.com/12-06-17-iantechinc483.pdf.
Read the LZR7 Form 483 here: www.fdanews.com/12-06-17-lzr7inc483.pdf.
Read the AccessClosure Form 483 here: www.fdanews.com/12-06-17-accessclosure483.pdf. — James Miessler
Creating Compliant CAPA Systems The first step in building a CAPA system is taking an inventory of the processes and data elements involved in manufacturing your products. The FDA regulation that deals expressly with CAPA is CFR 21 Part 820.100 — Corrective and Preventive Action for devices. The regulations identify specific minimum quality data that must be reviewed. These data include: processes, work operations, concessions, quality audit reports, quality records, service records, complaints and returned products. When choosing specific quality measures to monitor as part of the CAPA system, it is important to adopt the perspective that you are selecting data points that will identify deviations or problems, not just all available data, said Deborah Lydick, president of Catalyst Advantage Group. Management needs to be closely involved to ensure that the correct elements of each process are measured. “Obviously, understanding the indicators of your product and process performance is important to ensuring the effectiveness of your quality system,” Lydick said. “It also helps you understand the interrelationship across the process and across data elements.” Complaints hold special status for the FDA and typically concern products already on the market. Companies must be aware that the FDA expects complaints to trigger a CAPA investigation. If three defective products make it into the marketplace, expect the FDA to take action, and failure to trend complaints will be a violation the FDA will cite a company for in a 483. Excerpted from the FDAnews book: Creating QSR-Compliant CAPA Systems: A practical Guide for Devicemakers. |