Lusys Laboratories: A 16-item Form 483 highlighted a litany of QMS lapses uncovered at Lusys Laboratories’ San Diego, California plant during a Jan. 22-Feb. 7 FDA inspection.
The agency investigator found inadequate risk analysis, design controls and acceptance activities, failure to maintain a device master record, and failure to establish procedures for corrective and preventive actions.
The company manufactures IVDs for detecting hepatitis C virus, hepatitis B virus, human immunodeficiency virus, prostate specific antigen and Ebola virus.
Design control procedures didn’t provide instructions on how to perform and document design validation activities, and the risk analysis was inadequate, the investigator said. Lusys didn’t identify each potential failure mode for its IVD devices, the cause for the failure and the impact that the failure may have on the system and the end user, the agency said.
“Your risk analysis for these devices state that ‘no risk factors are expected in the design and development of the products[s]’ and that ‘the user may experience false positive, false negative or invalid results,’” the 483 noted.
The firm didn’t document activities or maintain raw data to demonstrate that its equipment could consistently perform according to predetermined parameters. It also didn’t establish procedures for acceptance activities, nor had it adequately maintained a device master record, according to the 483.
In addition, the firm had not initiated any corrective and preventive actions for nonconformities that were identified in 483s issued in 2015 and 2018. In addition, the company received a warning letter in 2015 for many of the same violations.
The firm was found to be lax in establishing QMS procedures such as management reviews, quality audits, document control procedures and personnel training.
New Life Diagnostics: Numerous quality management system lapses, including inadequate process control procedures and failure to initiate corrective and preventive actions were uncovered during a Feb. 25-27 FDA inspection of New Life Diagnostics’ Carlsbad, California plant.
The firm, which develops and manufactures a range of in vitro diagnostics for laboratory use, had not established quality control procedures that describe process controls to ensure conformance to specifications, the 483 said. Specifically, the IVD maker had not established quality control testing and product retention procedures for panel characterization and qualification and documentation of samples used in manufacturing and testing its ELISA IVDs.
Also lacking were procedures to ensure that equipment was routinely calibrated, inspected, checked and maintained. There was no documentation of installation qualification of one of the readers used to read microplate absorbance values of positive and negative control samples.
The standard operating procedure in question lacked “specific directions and limits for accuracy and precision, nor did it include provisions for remedial action to re-establish the limits to evaluate whether there was any adverse effect on the device’s quality,” the FDA said.
The IVD maker had no documentation for qualification of its suppliers, and acceptance activities were not documented. In addition, it failed to initiate CAPAs for nine complaints.
Stetrix: Design verification and validation procedures were found to be lax during a Feb. 5-6 FDA inspection at Stetrix’s Bartlett, Tennessee facility.
The design inputs for the Class II Hem-Avert peri-anal stabilizer were not adequately defined and documented, and they didn’t address requirements for physical and performance characteristics, sterility shelf life, labeling or packaging, and design inputs were not reviewed and approved by a designated person, the FDA said.
The specification developer failed to adequately document the design history file to confirm that design output met design input requirements. This was a repeat observation from a Nov. 7, 2008 inspection, and the firm was still unable to demonstrate that acceptance criteria was established for a verification study.
In addition, the facility couldn’t demonstrate acceptance criteria were established prior to the validation study, and results were not documented in the design history file.
The firm failed to evaluate potential risks associated with the sterility of the device and with a new indication for use in reducing the occurrence of caesarean delivery, the FDA said.
Read the Lusys Laboratories Form 483 here: www.fdanews.com/09-12-19-lusyslabsinc483.pdf.
Read the New Life Diagnostics Form 483 here: www.fdanews.com/09-12-19-newlifediagnosticsllc483.pdf.
Read the Stetrix Form 483 here: www.fdanews.com/09-12-19-stetrixinc483.pdf.
How to Maintain Complaint Files
A robust complaint handling process includes four broad stages:
One of the complaint unit’s chief responsibilities is to maintain complaint files, which are the records documenting all analysis conducted and actions taken when a company receives a complaint about a device.
Complaint handling procedures should lay out the structure of the complaint files in a way that will help ensure regulatory compliance and aid efficient management of the complaint process. That means devicemakers need file layouts that make it easy for the responsible staff to handle complaints. Each complaint record in the file should:
This can be achieved using an electronic system that employs such commonly used software as Excel or Access. However, any software used must be validated in accordance with 21 CFR 820.70(i), which addresses validating software for device manufacturing processes. This applies to custom software developed in-house, as well.
The Complaint Path
Regardless of the system used, an effective and compliant process will follow a certain pathway. When a manufacturer receives a complaint about a device, whether it is written, electronic or oral communication, the trained employees in the designated complaint unit must immediately take action.
Devicemakers need to note that complaints may come in to any part of a company. The complaint-handling process must include systems for funneling all complaints, regardless of where they are initially sent, into the designated unit.
For example, sales representatives and the people who service and maintain manufacturing equipment need to be trained in how to recognize a complaint and how to feed it back to the designated complaint unit.
Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.