On March 5, Moldex-Metric, Inc. in Culver City was issued 2 citations by the Food and Drug Administration (FDA) subsequent to an inspection, according to data posted on the FDA’s website.
Inspectors reviewed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate Moldex-Metric, Inc. was cited for:
- ‘Records of risk management activities in product realization were not maintained.’
- ‘A design and development file was not maintained for each medical device type or medical device family.’
The FDA routinely inspects facilities nationwide to determine whether workplaces and products comply with FDA regulations and laws intended to safeguard public health. Inspection reports are made available to the public.
According to its website, the FDA is a federal agency charged mainly with overseeing the safety and quality of human and animal drugs, biological products, medical supplies and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
