Drug, Device Violations in Dental Technologies Inspection

An FDA 12/7/20-1/20/21 inspection at Dental Technologies, Lincolnwood, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and Quality System (QS) regulations for medical devices. An 11/30 Warning Letter identifies the specific violations as: 

•          failing to thoroughly investigate any unexplained discrepancy or failure of a drug batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
•          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
•          failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
•          failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance;
•          failing to establish and maintain procedures to control medical device product that does not conform to specified requirements; and

1.          failing to conduct, control, and monitor production processes to ensure that a device conforms to its specifications. 

The letter says the firm’s quality systems are inadequate and gives citations to information on establishing and maintaining CGMP-compliant quality systems.

FDA further says the firm’s Paroex 0.12% chlorhexidine oral rinse is adulterated in that it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth and rendered injurious to health. The agency acknowledges the firm’s commitment to cease production of 0.12% chlorhexidine oral rinse.

FDA reminds Dental Technologies that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with application sponsors and product owners. And it recommends retaining a qualified consultant to assist the company in meeting CGMP requirements.

Dental Technologies was told to correct any violations promptly and respond with a list of specific steps taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.