Devices

Multiple Violations at Steiner Biotechnology

An 8/15-8/19/22 and 11/3-11/8/22 FDA inspection at Steiner Biotechnology in Henderson, NV, found multiple violations in the firm’s manufacturing and labeling of several dental bone grafting products. A just-released 5/19 Warning Letter says specific Quality System Regulation violations were:

failing to establish and maintain adequate procedures to control the design of a device to ensure that specified design requirements are met;
failing to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure;
failing to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failing to establish and maintain adequate procedures for acceptance activities, including inspections, tests, or other verification activities;
failing to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, including provisions for the handling, preservation, and storage of equipment so that its accuracy and fitness for use are maintained;
failing to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to adversely affect product quality, and failing to periodically inspect environmental control systems to verify that the system is adequate and functioning properly; and
failing to establish and maintain adequate procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements, and to determine the effectiveness of the quality system.

The letter says some of the inspection observations are repeated from an earlier inspection. FDA also says the firm’s products are adulterated because it does not have an approved PMA or IND in place for them. They are misbranded, it says, because Steiner did not notify the agency of its intent to introduce the devices into commercial distribution.

The letter further says the company failed to ensure that the label of every device contains a unique device identifier and failed to provide required information to the agency’s Global Unique Device Identification Database.

Steiner was told to promptly correct all violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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