Findings
1Material and supplier control
Your firm failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(2)). Your firm failed to qualify your suppliers and adequately test the components used to manufacture your finished drug products, including pediatric over-the-counter (OTC) (b)(4) products. For example, A. (b)(4) , one of your active ingredients is sourced from an unqualified supplier and was approved for use without establishing…
2Quality unit oversight
Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedure (21 CFR 211.22(d)). Your quality unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, A. You replaced the inactive ingredient with another inactive ingredient, without documented scientific rationale and justification, in multiple batches of your OTC drug products. For…
3Quality unit oversight
Your firm’s quality control unit did not review and approve written procedures for production and process control, including any changes to them, designed to ensure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess (21 CFR 211.100(a)). A. You failed to adequately validate your production and process controls. You did not have assurance that you are capable of consistently manufacturing OTC…
About this record
Extracted automatically from the document US FDA published on 2023-08-29. 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.
