Latest FDA Warning Letter

FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:  

Wilson Medicine Co. Nandore, India (9/11): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written procedures for production and process control designed to assure that its drug products have the identity, strength, quality, and purity they purport or are represented to possess. The firm also failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. Specifically, the agency said that analytical test methods used to determine acceptability of drug products prior to release for distribution are not validated (or verified, for USP compendial methods).
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm621038.htm