483 Roundup: FDA Cites Five Devicemakers for Procedural Failures

Five device manufacturers landed Form 483s from the FDA over their handling of complaints, medical device reporting, and corrective and preventive actions, among other deviations.

Peter Schiff Enterprises: The FDA issued a Form 483 to Peter Schiff Enterprises, citing validation issues, incomplete records and inadequate procedures.

The agency issued the form after an April inspection of the devicemaker’s Cookeville, Tenn., facility, during which investigators found that the company had not validated its sterilization process for its adult or pediatric electrode pads. The facility also did not maintain proper device history records for those devices. The records on file did not include the location of the label and labeling for each product lot or batch, according to the form.

The device history records also did not include full information on examination and release of labeling, including the date and the examiner’s signature. The firm also had not established an adequate plan for corrective and preventive actions, instead relying on a document that provided a rough outline for recording CAPA activities.

The company’s quality policy and objectives, meanwhile, were not established by management with executive responsibility or available in written form. The quality audit procedures found in the firm’s SOPs did not ensure compliance reviews for the quality system, and representatives could not produce any documentation of its management review procedures.

Tyson Bioresearch: Tyson Bioresearch landed a Form 483 from the FDA due to failure to establish adequate procedures for several operations.

A March inspection of Tyson’s Miaoli County, Taiwan, facility found the company failed to initiate corrective and preventive actions as required for deviations from its quality objectives in 2015 and 2016. Further, the firm had not validated a process used in production of its glucose test strips.

The firm’s handling of complaints also contravened its standard operating procedures. A review of several complaints related to the company’s blood glucose monitoring system found none contained documented evidence of an evaluation for medical device reporting.

Lastly, the firm’s written procedure for medical device reporting was simply a copy of the FDA’s MDR regulation.

OsteoSymbionics: Devicemaker OsteoSymbionics must correct several problems uncovered by FDA investigators, including CAPA procedures and non-conforming materials reports (NCMRs).

The FDA issued the company a Form 483 after a March inspection of its Cleveland facility. The inspection found the firm had not completed a CAPA opened in June 2015. Moreover, according to the form, the company’s NCMRs did not clearly document all investigative activities as required by the company’s own procedures. Ten of 14 NCMRs reviewed did not document why no investigation was required, and three had no information in the investigation and approval sections.

In addition, the company’s supplier files did not comply with the firm’s Supplier Evaluation and Selection SOPs, according to investigators, with several missing components such as evaluation records, up-to-date ISO certifications and supplier quality monitoring.

Lastly, according to the FDA, a heat sealer used for sterile packaging of the company’s cranial implants was calibrated for time and temperature but not for pressure, with the last calibration occurring nearly two years ago.

Southeastern Technology: Following an FDA inspection, Southeastern Technology faced sanctions for its process control procedures and personnel training.

In an April inspection of the firm’s Murfreesboro, Tenn., facility, the FDA faulted the devicemaker on its process controls for the cleaning line as identified by its SOPs. Investigators interviewed a cleaning line operator and a regulatory compliance manager and found the facility did not use its conductivity meter to verify cleaning solution concentration, even though the company’s cleaning tank solution test log was fully filled out.

The FDA also noted that the facility did not maintain documented personnel training records.

Innovative Sterilization Technologies: Problems with Innovative Sterilization Technologies’ CAPA procedures, complaint handling and MDR processes earned the devicemaker a Form 483.

The FDA issued the form following an April/March inspection of the firm’s Dayton, Ohio, facility. Investigators noted numerous problems with the facility’s CAPA procedures. The company SOPs had no clear definition of “unfavorable trend,” and the company failed to initiate a CAPA in response to trends that required one according to the SOPs.

The company’s complaint SOP, meanwhile, did not properly define how to document investigations and complaint closures for cases where the device was not returned for evaluation. The company voided nearly 50 complaints because the product was never returned.

The agency also faulted the company on its procedures for validating sampling methods, finding that the SOPs did not define their selection and use. Lastly, the company’s written MDR procedure did not include a system to determine when a complaint qualifies for reporting.

The 483s can be read here: www.fdanews.com/06-29-17-Five483s.pdf. — Zack Budryk