WL Washington Homeopathic Products, Inc. - JUNE 19, 2020
3. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Your firm failed to adequately validate the test method you used to analyze your raw materials and finished drug products for microbiological attributes. You attempted to validate your test method, but you failed to:
• Verify the suitability of your method under actual conditions of use
• Perform method suitability for all products manufactured by your firm to ensure your firm is capable of culturing organisms that may be present
• Establish a validated method for detecting objectionable microorganisms in your homeopathic drug products
• Perform method suitability for all products manufactured by your firm to ensure your firm is capable of culturing organisms that may be present
• Establish a validated method for detecting objectionable microorganisms in your homeopathic drug products
