Findings
1Material 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 manufacture several over-the-counter (OTC) drug products, including some intended for pediatric use. Based on our inspection, you failed to test a representative sample of your incoming high-risk components for diethylene glycol (DEG) or ethylene glycol (EG) contamination. These components include, but are not limited to, glycerin and sorbitol…
2Quality unit oversight
Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your quality unit (QU) lacked control over your drug manufacturing operations and failed to ensure that you had adequate procedures. For example, your QU failed to ensure the following: Establishment of a written testing program designed to assess the stability characteristics…
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)). You have not adequately validated your production and process controls used to manufacture your drug products, including Sprinjene Natural Toothpaste. Without adequate validation, you have insufficient assurance…
About this record
Extracted automatically from the document US FDA published on 2025-10-14. 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.
