The Food and Drug Administration (FDA) cited All Quality & Services, Inc. in Fremont five times during an inspection conducted April 10, FDA data show.
The inspection examined these areas:
- Compliance: Devices
- Postmarket Assurance: Devices
The company was cited for the following issues, as listed on the FDA website:
- ‘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 conducts inspections nationwide to verify that facilities and their products comply with laws and regulations designed to safeguard public health. Results of these inspections are released to the public.
The agency is responsible for overseeing the safety and quality of human and animal drugs, biological products, medical devices, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
