Findings
1Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Performance of periodic (i.e., at least annually) product reviews for all of your drug products (21 CFR 211.180(e)). Use…
2Process validation
Your firm failed to establish adequate 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 validated your manufacturing process used to produce homeopathic drug products, including those intended for infants and children. During the inspection, you indicated that you were not aware of the…
3Material and supplier control
Your firm failed to appropriately sample, test, or examine the components, containers or closures released for use in the manufacture of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84). As a contract manufacturing organization (CMO) of homeopathic drug products, you failed to perform adequate identity testing of each drug component lot used in the manufacture…
About this record
Extracted automatically from the document US FDA published on 2024-02-06. 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.
