FDA 483 - A. R. Hinkel Company, Inc. dba R.A.Fischer - January 24, 2020

A. R. Hinkel Company, Inc. dba F.A. Flechog, a medical device manufacturer in Simi Valley, CA, was cited with two observations during an FDA inspection. The observations highlight deficiencies in process validation for soldering and inadequate procedures for controlling and documenting nonconforming products. These issues indicate a need for improved adherence to quality system requirements.