Findings
1Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate identity testing on each shipment of each lot of incoming components (for example, (b)(4) ) used in the manufacture of…
2Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your cleaning validation program for non-dedicated manufacturing equipment, used for multiple drug products, is inadequate. It does not include the equipment used in tablet manufacturing, such as Intermediate Bulk Container (IBC) tanks (b)(4) tanks, product transfer hoses and (b)(4) hoses. Additionally, your firm lacks equipment usage logs and…
3Process validation
Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You have not adequately validated your production and process controls used to manufacture your homeopathic drug products, including “ (b)(4) tablets” and “ (b)(4) ,” which are labeled for (b)(4) . Your drug products contain…
About this record
Extracted automatically from the document US FDA published on 2025-12-23. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
