During a Jan. 30 inspection, the Food and Drug Administration (FDA) issued six citations to Element Materials Technology Oakland-Concord in Concord related to Drug Quality Assurance, according to data posted on the FDA’s website.
The FDA’s online records show the company received citations for the following issues:
- ‘The responsibilities and procedures applicable to the quality control unit are not fully followed.’
- ‘Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.’
- ‘Routine inspection of mechanical equipment is not performed according to a written program designed to assure proper performance.’
- ‘Established test procedures are not followed.’
- ‘Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.’
- ‘Laboratory records do not include a record of all calculations performed in connection with the test.’
The FDA conducts regular inspections at facilities nationwide to verify compliance with FDA-regulated laws and regulations designed to protect public health. Outcomes of these inspections are made public.
The agency’s website states the FDA is a federal entity focused on overseeing the safety and quality of human and animal drugs, biological products, medical supplies and tobacco products.
Information for this article comes from the U.S. Food and Drug Administration. The original source data is available here.
