Food and Drug Administration records reveal All Quality & Services, Inc. in Fremont was cited five times during an April 10 inspection, according to data published on the FDA’s website.
Inspection topics included:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA data details the following findings issued to the company:
- ‘Written MDR procedures have not been developed.’
- ‘Records from management review were not adequately maintained.’
- ‘Process(es) for establishing competence, providing needed training and ensuring personnel awareness have not been adequately documented.’
- ‘Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation, and disposition of nonconforming product were not adequately documented.’
- ‘Corrective action procedures defining the requirements for reviewing nonconformities, determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, planning and documenting action needed and implementing such action, verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device and reviewing the effectiveness of corrective action taken have not been adequately documented.’
The FDA carries out regular facility inspections nationwide to verify workplace and product compliance with health and safety regulations. These results are made publicly available.
The FDA states on its website that it serves as a government agency responsible for overseeing the production and distribution of human and animal drugs, biological products, medical devices and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
