FDA WARNS DENTAL SUPPLY FIRM ABOUT LAX QUALITY CONTROLS
The FDA issued a June 1 warning letter to Dux Industries of Oxnard, Calif., citing the company for failing to document quality controls and management review procedures, and for lacking a system to receive and review product complaints.
The company makes temporary dental cement and impression materials, sterilizing pouches and "tissue management materials," such as "drug impregnated" dental braids, knits and cords.
Following an inspection conducted March 21 through April 10, the FDA said the devices are "adulterated" because of current good manufacturing practice and quality system regulation violations. The FDA's letter cites Dux for specific violations, including:Failing to establish internal audit plans for 2005 and 2006; Not maintaining written documentation that defines the quality practices, resources and activities relevant to the devices Dux designs and manufactures; Failing to maintain written management review procedures or document management reviews;
Failing to document and describe the evaluation of potential causes of nonconformity or other quality problems once they have been identified; and
Lacking procedures to determine whether complaints should be reported.