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) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Establishment of adequate written responsibilities and procedures applicable to the…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol- (b)(4) . You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade…
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)). Your firm failed to adequately validate the processes used to manufacture your OTC drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an adequate ongoing program…
About this record
Extracted automatically from the document US FDA published on 2026-08-04. 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.
