FDA 483 - NeuroField, Inc. - October 06, 2021

NeuroField, Inc. in Bishop, CA, a medical device manufacturer, was issued a Form FDA-483 with six observations following an inspection from September 28 to October 6, 2021. The inspection revealed significant deficiencies across multiple quality system procedures, including complaint handling, corrective and preventive actions, supplier control, equipment maintenance, management review, and internal quality audits. Many of these issues were noted as similar to observations from a previous inspection in 2018, indicating persistent systemic problems.