483 Roundup: Devicemakers Come Up Short on Documentation, Reporting

The FDA cited four devicemakers for a variety of problems observed during inspections, including a lack of written quality procedures, shipping products prior to approval, inadequate documentation, and failure to report a software change.

Duralife-USA LLC in South Williamsport, Penn., was cited for failing to maintain documentation of quality control procedures or systems. An FDA inspection in late January and early February found the company lacked written quality systems or procedures, according to a Form 483.

Inspectors found the company had no written procedures for: quality control, corrective and preventive actions: MDR procedures: receiving, reviewing and evaluating complaints; device labeling; or evaluation of potential suppliers.

Documentation of device master records, history records or design history records for some products also were nonexistent, according to the Form 483.

Lingraphica America: A February inspection of Lingraphica America Inc. in Parsippany, N.J. revealed the company shipped products before they were approved for distribution. In a least three instances in 2016, Lingraphica shipped its speech pathology devices as much as four weeks ahead of the documented date of approval for distribution.

Inspectors also found problems with document controls in multiple departments and with overall training procedures and documentation, according to the Form 483. Device acceptance procedures also were not properly documented, with inventory and manufacturing dates failing to align in the company’s forms.

EMED Technologies Corp.: Design documents were not properly updated and maintained at EMED Technologies Corp. in El Dorado Hills, Calif., the FDA found in an inspection carried out from Jan. 27 through Feb. 7.

The company failed to implement its document control procedures, with inspectors noting that the DCR was approved for a device to be used with a particular drug on Oct. 10, 2016 but FDA clearance for the pairing was not granted until Dec. 1, 2016.

Also, labeling of EMED’s marketing materials and on the company’s website did not meet regulatory requirements, according to the Form 483.

Hitachi Medical Systems America: A correction made ostensibly to reduce a possible health risk posed by a medical device made by Hitachi Medical Systems America in Twinsburg, Ohio was not properly reported, the FDA found, in a Jan. 18-Feb. 6 inspection. Urgent software changes were sent from the parent company and implemented locally, but the Twinsburg facility failed to notify the FDA of the change, the agency said in the Form 483.

Other corrective actions, made by suppliers, were not made according to the company’s CAPA or with proper documentation. Inspectors also found that complaint files were not properly maintained, including risk analysis and risk documents in the design history files.

In addition, the facility failed to identify the root cause of adverse events in 5 of 9 MDR reports of serious industries. The company also failed to update its risk analyses documents with post market data.

The FDA investigator also noted the firm had not initiated a supplier corrective action or properly managed a problem with non-conforming covers for an MRI device. The supplier’s drawings of the covers did not align with the Hitachi specifications, but the discrepancies were not documented in the non-conforming system.

The companies did not return requests for comments.

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