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The QMN Weekly Bulletin

FDA Cites Lusys Labs for Design Control, Other Procedures

April 7, 2017

Lusys Laboratories in San Diego, Calif., failed to establish design control procedures and ensure that equipment met specifications, the FDA said, in a Form 483.

An inspection of the company’s San Diego, Calif., facility in October through December 2016 revealed that the company had not established design control procedures for several of its Zika virus test, FSH one-stop menopause test, and in vitro diagnostic devices.

Lusys also failed to provide documentation of design control activities to justify the data used to support the expiration dates for finished IVDs.

The inspector further observed that certain equipment was not shown to meet specifications. In addition, the facility had inadequate procedures for acceptance of in-process and finished IVDs.

The Form 483 also reported that device master records did not include or refer to the location of device specifications, production process specifications, quality assurance procedures and specifications, and labeling specifications for several IVDs.

In addition, the agency faulted Lusys for its procedures for handling out-of-spec or expired materials. Required forms were not filled out, expired products were not properly identified, and no investigation was conducted into the root cause of the issues, the agency said.

Lusys failed to document or implement the supplier evaluations as the firm’s procedures required. It also did not maintain an approved supplier list.

The firm’s CAPA procedures lacked instructions for carrying out key requirements, such as analyzing quality data sources to identify causes of nonconforming products. Other observations included failing to properly review complaints, to control environmental conditions, or to maintain device history records.

Command Medical: Command Medical Products received a Form 483 for inadequate environmental monitoring and CAPA procedures.

During an inspection of the company’s Ormond Beach, Fla., facility in December, the FDA noted the firm lacked adequate procedures to control environmental conditions. For example, the suitability of some sampling methods was not established, particle counts in clean rooms were not conducted under worst-case conditions, and biological indicators were not stored in a temperature-controlled room.

One CAPA procedure failed to include requirements for analyzing processes, work operations, quality records, complaints, returned products, and other sources of quality data to identify sources of quality problems. Other CAPAs were not logged into the firm’s quality database in accordance with procedures.

The investigator additionally faulted process control procedures. A tubing extrusion procedure did not describe how a required evaluation would be conducted, and a setup procedure did not describe how a particular tool would be inspected.

Acorn Stairlifts: Acorn Stairlifts drew a Form 483 from the FDA for inadequate CAPA procedures and other issues at its facility in Orlando, Fla.

In a December 2016 inspection, the investigator observed a lack of follow-up to complaints — including one reported to the FDA as a serious injury — regarding the weight capacity of seats; and procedures that did not require all CAPAs to be validated as effective.

The FDA also said the company lacked approved procedures to ensure proper evaluation of supplier operations, including welding and molding, training, and environmental controls.

The firm initiated field correction of seats on some of its stair lifts in the United States in April 2016, following reports of the seats breaking. But it failed to provide evidence that the correction/removal was reported to the FDA.

The investigator also faulted Acorn for not establishing proper internal quality audits. The firm’s internal audit standard operating procedures were found to be inadequate for various reasons. They did not require audits to be conducted at a specific frequency and they lacked criteria for what would be covered during audits. In addition, they lacked training requirements for auditors, and they failed to include requirements for management responsibility, document control, and other procedures.

The facility also lacked proper procedures to control environmental conditions.

QSR says you must maintain, inspect and make adjustments to your equipment. What the nine-paragraph rule doesn’t say is how. Three Phases of QSR-Compliant Equipment Control helps fill in the gaps. Order your copy to understand QSR requirements for the installation, operation and maintenance of your manufacturing equipment.

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