483 Roundup: Four Firms Flagged for Quality and Other Failures

Republic Spine: Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida facility.

The devicemaker received a five-item Form 483 for deficiencies related to its Dark Star triple-lead pedicle spinal screw system.

A complaint handling procedure did not include requirements for transmitting medical device reports to the FDA and it lacked documentation and recordkeeping requirements. The firm also failed to fully implement design control procedures, the agency said, pointing to inadequate design planning, design verification, design validation, design reviews and design changes.

For example, the design plan did not include a development schedule with all tasks, review stages and milestones clearly defined, nor did it identify all contributors to the development process and their responsibilities. The design history file also lacked evidence that the design verification was performed on the physical characteristic input requirements listed on the design input/output matrix, the FDA said.

Moreover, there was no approved protocol in the design history file to perform design validation to include an explanation for a simulated environment. The investigator found two different design development validation forms with different dates and no explanation for the discrepancy.

The FDA said the firm’s risk analysis was inadequate in that it failed to justify how it arrived at certain ranges for the spinal system, and some of the risk mitigation methods did not describe changes implemented to mitigate risk. The firm was also not using feedback such as complaints to review its failure mode effects analysis (FMEA) to “determine if new hazards have been identified and may require mitigation.”

For example, one complaint identified a new at-fault hazard of device fractures due to improper continuous loading/unloading, but the hazard was not added to the FMEA document.

Greenwald Surgical: Greenwald Surgical landed a Form 483 for failing to document rework and reevaluation activities for its surgical products.

A March 2018 inspection of its Lake Station, Indiana facility revealed that the maker of urological and electrosurgical instruments and accessories didn’t document nonconforming subassemblies used in manufacturing finished products as nonconforming, and instead reworked them without documentation or evaluation, according to the Form 483.

Assembly operators told FDA inspectors that flexible endoscopic electrodes that failed an in-process inspection were repaired and retested, but the nonconforming product was not documented as nonconforming and the process of repairing the product was not documented as rework, the agency said.

The FDA also found fault with the firm’s device acceptance procedures because they did not ensure that acceptance activities required by the device master record were completed.

Electro Cap International: Failure to validate its products and undefined rework of nonconforming product, as well as other quality system failures, landed Electro Cap International a Form 483 following a March 2018 inspection of its Eaton, Ohio facility.

The firm failed to validate its induction sealer used for sealing its Electro-Gel jars that was installed in February 2015. The president of the firm told inspectors that there were no records documenting the validation of the sealer.

The FDA inspectors noted that five of eight product nonconformity reports included rework processes for the firm’s electro caps, but the rework processes were not defined or approved.

The device history record didn’t demonstrate that the devices were manufactured according to the device master record, because it didn’t include all process steps defined in the device master record, the agency said.

The FDA noted that in-process acceptance is defined for each assembly stage in the device master record but there was no documentation for in-process acceptance.

The agency also cited the firm for inadequate design change procedures because it didn’t document changes made to its manufacturing process of the electro-gel. The agency also flagged the firm for inadequate corrective and preventive actions, because it wasn’t analyzing repairs and service of its product “as a quality data source to identify existing and potential causes of nonconforming product or other quality problems.”

American Thermal Instruments: The FDA called out American Thermal Instruments, a devicemaker based in Moraine, Ohio, for failing to evaluate suppliers and receive notifications of product changes, in addition to having device master record problems.

The agency’s February inspection revealed that the firm did not complete evaluations of potential suppliers and contractors. The company lacked agreements between suppliers and contractors that ensured notifications of any changes in products or services.

The firm also had device master records that were not properly maintained. The work instructions contained in two device master records were incorrect and the company did not maintain its electronic device master records as instructed by its procedure.

In addition, CAPA procedures failed to identify all quality data sources that would be analyzed to determine that a CAPA is necessary. The procedures did not include a statistical method for analyzing data. The firm also did not have a procedure for handling supplier corrective action requests.

Read the Republic Spine Form 483 here: www.fdanews.com/07-02-18-republicspinellc483.pdf.

Read the Greenwald Surgical Form 483 here: www.fdanews.com/07-02-18-greenwaldsurgicalcompanyinc483.pdf.

Read the Electro Cap International here: www.fdanews.com/07-02-18-electrocapinternationalinc483.pdf.

Read the American Thermal 483 here: www.fdanews.com/07-05-18-americanthermal483.pdf.