FDA 483 - Eden's Answers Inc - August 14, 2019

Edel's Answers Inc., an OTC drug manufacturer in Millersburg, OH, was cited for multiple significant deficiencies during an FDA inspection. Observations included a lack of an adequate quality control unit, absence of drug product specifications and stability data, insufficient employee training, and inadequate equipment calibration and cleaning procedures. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.