Findings
1Material and supplier control
Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)). Your firm failed to ensure that components used in the manufacture of your over-the-counter (OTC) (b)(4) drug product “ (b)(4) ” are suitable for their intended use. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4) ). Products Contain Ingredients…
2Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm has inadequate microbiological release specifications for your OTC drug products…
3Process 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)). Lack of Process Validation You failed to validate your production and process controls. Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each…
About this record
Extracted automatically from the document US FDA published on 2026-05-19. 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.
