Findings
1Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). Your firm lacked an adequate stability program to demonstrate that the chemical and microbiological properties of your Hongosan Anti-Fungal Set and Hongosan Premium Plus Spray drug products remain within…
2Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm released Hongosan Premium Plus Spray and DSP Skin Care Hand Sanitization Gel over-the-counter (OTC) drug products without testing to ensure that they met their identity, purity, strength, and other…
3Quality 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 firm lacked written procedures detailing the roles, responsibilities, and duties of the quality unit (QU) to ensure that QU functions are accurately performed and that drug products meet quality standards. For example, your firm lacks…
About this record
Extracted automatically from the document US FDA published on 2022-08-02. 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.
