FDA 483 - K+S Minerals and Agriculture GmbH - June 14, 2018

An FDA inspection of K+S KALI GmbH, an API manufacturer in Philippsthal, Germany, revealed two significant observations. The firm's laboratory controls were found to be deficient, specifically regarding the uncontrolled issuance of GMP test plans and lack of safeguards for raw data. Additionally, the company's procedures for reserve samples did not include annual visual examination for deterioration.