483 Roundup: FDA Hits Three Firms Over MDRs, Complaints, and Records

The FDA cited three devicemakers for a range of deficiencies including inadequate procedures for device failures, MDRs, complaints, and recordkeeping.

GFS Chemicals: An Ohio contract manufacturer of medical devices failed to maintain adequate records for its manufacturing processes, failed to set requirements for suppliers and lacked procedures for conducting quality audits or handling complaints, the FDA said.

The company, GFS Chemicals, of Columbus, sells laboratory equipment and chemicals to a variety of customers, including pharmaceutical firms.

The FDA reviewed the facility’s production processes and protocols going back 10 years in an inspection conducted in March, and found the company’s device history records were incomplete and showed that the facility failed to follow its manufacturing procedures.

The agency also found the facility lacked validations for some manufacturing processes and failed to spell out procedures and documentation for changes in methods, such as a 2009 switch from an operation that previously was conducted manually.

In addition, the agency found the company’s CAPA documentation was inadequate.

Columbia Scientific Development: Columbia Scientific Development did not properly investigate potential device failures or develop written MDR procedures, according to the FDA.

The agency issued a Form 483 following a May/June inspection of the medical device specifications developer’s Portland, Ore., facility. Investigators found Columbia’s complaint handling procedure did not require investigating complaints involving possible failures of devices, their labeling or their packaging. Two of four complaints documented since May 2016 related to potential problems with the company’s electrode devices, but the company documented that both were closed without an investigation.

The FDA faulted the company’s MDR procedures, noting that it did not have an internal system for identifying and submitting supplemental or follow-up reports or submitting MDR events to the agency.

The company’s complaint-handling procedures required all oral or written complaints to go on the firm’s official complaint document, but the firm only documented two out of four complaints about its electrodes.

The company’s design history files did not demonstrate that the design complied with requirements and the company did not document validation of the device design, the agency said. In addition, the firm’s procedures required reviews for management and subcontractor performance but there was no documentation of the reviews taking place.

The Form 483 further noted that the company’s design control procedures did not require that design reviews be documented in meeting minutes, and its device master record for the Columbia 600B electrodes do not include all required information. Device history record procedures were also incomplete, with seven failing to include or reference the location of UDI coding on the label.

Lastly, the firm’s document control procedures require authorized approval signatures, but at least three procedures were implemented without one, and documents stamped “HISTORY” were mixed in with current documents, contrary to company procedures.

Tate Technology: Tate Technology failed to properly evaluate complaints or keep records of nonconformances, according to the FDA.

The FDA issued a Form 483 to the devicemaker following a June inspection of its Spokane, Wash., facility. Investigators found the firm’s procedures for handling complaints did not include a requirement that all medical device complaints be evaluated for medical device reporting, and it did not document an MDR evaluation for any of 12 complaints received since last January.

Moreover, according to the agency, the company did not keep records of “Red-Tag” nonconformances for medical devices. The facility’s quality manager told investigators that the tags were disposed of as soon as the nonconformance was handled.

In addition, Tate’s procedures for supplier selection and evaluation did not feature requirements for suppliers, contractors and consultants regarding medical devices, and the company failed to document its evaluation of potential suppliers.

The firm’s procedures further allowed for the use of unapproved suppliers, and had no agreements in place with contractors or suppliers to alert Tate of changes to their products or services.

Read the three Form 483s here: www.fdanews.com/08-02-17-ThreeForm483s.pdf. — Zack Budryk and Gregory Roberts