1. Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.
Your firm manufacturers homeopathic in process materials and [redacted] from various raw materials. Our investigator observed unidentified debris in the [redacted] of your [redacted] equipment, which is used to process multiple raw materials for homeopathic [redacted], including [redacted] containing [redacted]. This equipment was marked as clean.
Your response states that you filed a deviation and re-trained your staff. This response is inadequate because you failed to identify the observed debris and perform an impact assessment for the drugs that were manufactured using this dirty equipment.There are API in homeopathic remedies? How do they test for them? What's the limit of detection?*
*I’m sure there’s some way