Transox Inc – FDA Warning Letter, Nov 20, 2014

On November 13-20, 2014, an FDA inspection of Trans Ox, Inc.'s pharmaceutical manufacturing facility revealed significant violations of CGMP regulations (21 CFR Parts 210 and 211), rendering their drug product adulterated.

Key violations include: 1. **Lack of Appropriate Laboratory Determination (21 CFR 211.165(a))**: The firm lacked proper documentation for batch release. Batch production records contained erroneous statements, including purity results not derived from analytical testing or supplier Certificates of Analysis (CoAs). The "Post Fill Purity Test" results, purportedly from a (b)(4) Oxygen Analyzer, were contradicted by an FDA investigator's observation that the analyzer was unused and the general manager's admission that values were from CoAs. Discrepancies were noted between batch records (e.g., Lot 011514, 032614 showing 99.9% purity) and supplier CoAs (e.g., 99.74%, 99.84% purity for corresponding lots). The firm's response, including a new Policy and Procedure Manual, was insufficient as it lacked retrospective reconciliation of records or testing of existing stock.

2. **Inadequate Quality Control Unit (QCU) (21 CFR 211.22(a))**: The firm failed to establish