Findings
1Process 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 failed to ensure adequate process validation for the OTC drug products you manufacture, including those indicated for infants and children. For example, you have not performed adequate process validation for the…
2Quality unit oversight
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)). You manufacture over-the-counter (OTC) oral liquid drug products including, but not limited to, analgesics and cough and cold products marketed for infants and children. You failed to ensure adequate quality unit (QU) oversight for release of your OTC drug products. For example, your QU failed to…
3Material 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)). You failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination prior to use in manufacturing. For example, glycerin and sorbitol solution were used to manufacture your OTC oral drug products marketed for infants and children prior to obtaining results for identity testing of the…
About this record
Extracted automatically from the document US FDA published on 2025-12-09. 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.
