FDA 483 - Encision Inc. - September 20, 2019

Encision Inc., a medical device manufacturer in Boulder, CO, received an FDA Form 483 citing significant deficiencies in its quality system. Observations included inadequate control over non-conforming product, insufficient procedures for corrective and preventive actions, and failures in establishing and adhering to complaint handling processes. These issues collectively indicate a need for improved procedural controls and compliance.