Neotech Products, LLC – FDA 483, Jun 9, 2022

Neotech Products, LLC, a Class I & II medical device manufacturer in Valencia, CA, was cited for three observations during an FDA inspection. The observations primarily concern inadequate documentation of corrective and preventive actions, insufficient procedures for finished device acceptance, and deficiencies in design verification record-keeping. These issues indicate a need for improved quality system controls and adherence to regulatory requirements.