483 Roundup: FDA Cites Three Firms for Quality, Documentation Failures
The FDA issued Form 483 reports to three devicemakers over inadequate quality procedures and documentation.
Hebei Pukang Medical Instruments: The FDA cited Hebei Pukang Medical in Hebei, China for its design control and quality processes.
The agency issued a Form 483 following a January inspection of the electric hospital bed manufacturer’s facility.
The company’s Class II AC-powered adjustable hospital beds did not go through the design control process, and the firm had not established design control procedures, according to the Form 483.
The firm has been shipping the AC-Powered Adjustable Hospital Beds to the U.S. for 10 years.
The agency also cited the firm for lack of CAPA procedures or device history records. Investigators found several cases of beds manufactured for the U.S. market with no device history records to show compliance with the device master records.
Other deficiencies included damaged pumps on wheeled stretchers, an infant hospital bed with the wrong frame and rust on a hydraulic bed. The firm also conducted no quality audits to ensure its quality system was compliant and effective.
Invacare: The FDA faulted Invacare on its supplier controls and quality documentation.
The agency issued the devicemaker a Form 483 following a May/June inspection of its Elyria, Ohio, facility. The inspector found Invacare’s supplier controls procedure failed to define levels of control or quality requirements for affiliates, with the documentation stating the only affiliate requirement was to be listed on the Approved Supplier List.
The supplier files were also insufficient, lacking required documentation such as completed supplier agreements, and procedures did not define how a supplier is moved from “approved” to “conditionally approved” or “restricted” status.
Invacare Way failed to adequately control all of its suppliers, the FDA stated in a report that resulted from a recent inspection of the medical device manufacturer’s procedures.
The agency outlined specific examples of Invacare’s flawed and outdated control procedures, including the lack of “all necessary quality documentation” in its supplier files and the use of an expired protocol.
Investigators also found the company’s motor supplier has been listed on “restricted” approval status since 2012 and currently uses a protocol that expired in 2013. The manufacturer promised to address the issues.
The Metz Dental Laboratory: The Metz Dental Laboratory in Columbus, Ohio drew a Form 483 for problems observed in a May 16-22 inspection, including a lack of design validation procedures.
The facility failed to verify that the design output met design input requirements, the agency said.
The company also lacked a design history file and a device master record for the Metz Appliance device.
The FDA also noted the company’s device history records did not include all of the labeling applied to each device. The agency also found inadequat4 document control procedures
The facility’s device history records did not include all of the labeling applied to each device. For example, the usage and home care instruction and seating instructions for the Metz Appliance were not included in the device history files.
In addition, not all the firm’s quality documents were processed in accordance with the firm’s document control procedure. For example, the design plan, design control traceability matrix, preliminary hazard analysis, design specifications, and bill of materials were not identified and added to the quality document master index.
Read the three Form 483s here: www.fdanews.com/08-25-17-ThreeForm483s.pdf.