Findings
1Stability and storage
Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products. (21 CFR 211.166(a)) The records and information you provided did not demonstrate that the chemical and microbiological properties of your drug products remain acceptable throughout the labeled expiry period. For example, your February 26, 2025, response states that there was no stability data to support the (b)(4) shelf life for (b)(4) shipped…
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)) Based on the records and information you provided, you did not demonstrate that you tested the identity of incoming components including (b)(4) used to manufacture your OTC drug products. For example, your February 26, 2025, response states that you do not perform identity testing for your components before use in manufacturing. You also did not…
3Quality unit oversight
Your firm failed to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures. (21 CFR 211.22(d)) The records and information you provided demonstrate that you failed to implement written procedures to establish a quality unit (QU) with the CGMP responsibilities and authority to oversee the manufacture of your OTC drug products. For example, your response indicated there were no QU procedures for change…
4Aseptic processing and sterility assurance
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to ensure conformance with appropriate standards of identity, strength, quality, and purity. (21 CFR…
5Process 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)) Lack of Process Validation In your response to our 704(a)(4) request, you stated that no validation activities have been performed for your drug products, including (b)(4) . Process validation evaluates the soundness of…
About this record
Extracted automatically from the document US FDA published on 2025-09-16. 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.
