Regulatory Focus™ > News Articles > 2020 > 7 > Updated: Device manufacturers warned by FDA for consumer complaint handling

Updated: Device manufacturers warned by FDA for consumer complaint handling

Posted 07 July 2020 | By Kari Oakes 

Updated: Device manufacturers warned by FDA for consumer complaint handling

The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).
Luminex Corporation
Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspection that found problems with change validation, servicing activities, and monitoring of process parameters. The inspection also found that the firm had not documented the selection and evaluation process for critical suppliers, nor had it maintained purchasing data specifying requirements for suppliers.  
A processor made by Luminex failed, resulting in false-negative assay results; the patient with the false negative results had multi-drug resistant Pseudomonas-positive infection identified from blood cultures. The patient, whose therapy was delayed, died two days after the blood culture results were reported.
“The false negative device result may have led to a missed opportunity to initiate effective treatment earlier. The risk of false negative results could be the inappropriate de-escalation or lack of escalation of antibiotic therapy until subculture sensitivity testing was completed,” said the FDA.
Additional false negative results occurred after this event. The device in question received field service and was later removed. ”FDA finds that the removal of this instrument was initiated to reduce a risk to health, and this was not reported to FDA,” noted the letter.
The agency found the Corrective and Preventive Actions (CAPAs) initiated by Luminex inadequate, and responses to the false-negative problems with the processor to be lacking as well. “Your firm responses have not included any actions you have taken, or plan to take, to report the medical device removals for these devices and any other corrections or removals that are required to be reported,” wrote FDA.
Greiner Bio-One North America, Inc.

Greiner Bio-One North America, Inc. (Greiner) manufactures blood collection tubes. During a December 2019 inspection, FDA officials found issues with follow-up of several problems with clinical use of the tubes, including cap separation, slow fill rates, cracking and leakage during pneumatic tube transport, and inaccurate hemoglobin levels with use of one lot number.
Other issues identified included recycled materials being used without validation. Also, the firm failed to establish procedures for finished device acceptance, including inadequate procedures for taring test containers before filling and a failure to record or provide ambient temperature and pressure.
FDA inspectors also found that injection molding machines were overdue for calibration; also, sampling plans were not based on a valid statistical rationale. Among other problems with Greiner’s sampling plans, “There is no procedure to investigate the cause of a first analysis which identified a nonconformance and was not used,” noted the letter.
The agency did also note that Greiner has opened CAPAs on these issues; the effectiveness of remediation measures will be evaluated in a following inspection, said the letter.
The agency also warned the firm for failure to respond in adequate and timely fashion via the medical device reporting process to consumer complaints. “There is no information included for the complaint that justifies that the malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Your firm became aware of the event on May 15, 2017 but didn’t submit an MDR for the referenced event,” noted the warning letter regarding one such complaint.

"Upon receiving observations from the FDA during an inspection in December 2019, we acted swiftly to implement corrective actions and are cooperating with the FDA to resolve all issues," said A.C. Marchionne, Greiner's president and chairman of the management board, in a press statement responding to the warning letter.
Vega Life Sciences Private Limited

Vega Life Sciences Private Limited was warned for failure to control and monitor solvent recovery procedures, cleaning procedures that were inadequate, and for data integrity issues. The problems were discovered during a November 2019 inspection.
The firm did not follow their own gas chromatography test procedures and had not established an impurity profile for recovered solvents. “Unknown peaks observed in chromatograms of recovered solvents may represent unanticipated impurities that can impact the quality of your customer’s API and should be thoroughly investigated,” noted the warning letter.
Problems with cleaning procedures included a lack of records documenting cleaning of nondedicated processing equipment, indicating failure to ensure that carryover or contamination was not occurring with use of nondedicated equipment.
Data integrity issues included missing raw data files, sharing of usernames and passwords, and lack of backup systems and audit trail retention procedures.
Vega Life Sciences has agreed to terminate solvent recovery operations for the US market, noted the letter, which also recommended that the firm retain a current good manufacturing practices (CGMP) consultant to achieve remediation of the issues referenced.

This article was updated on 22 July 2020 to include the response from Greiner Bio-One North America, Inc. 

Tags: devices, FDA, medical, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.