FDA WARNING_LETTER - Miami University Department of Chemistry and Biochemistry - November 05, 2021

The FDA issued a Warning Letter to Miami University's contract testing laboratory following an inspection from November 1-5, 2021, identifying significant deviations from CGMP for active pharmaceutical ingredients (API), specifically crude heparin and API heparin sodium, USP. The API are considered adulterated.

Key violations include: 1. **Failure to control computerized systems and prevent data omission/falsification:** An analyst "falsified" (b)(4) data from 2018-2021 by entering arbitrary values, which was discovered during a customer audit immediately before the FDA inspection. The firm's quality system did not ensure data accuracy or integrity, and the FDA disagreed with the firm's conclusion that data manipulation was only to avoid reanalysis, stating results were unreliable. 2. **Inadequate Quality Unit (QU) and quality system:** The firm lacked an established QU and procedures for CGMP testing prior to FDA contact. Procedures were created shortly before the inspection and lacked sufficient detail or evidence of implementation. 3. **Inadequate employee training:** Laboratory personnel, including faculty and graduate students, lacked documented CGMP training. Training procedures were created just before the inspection, and no retrospective assessment of personnel expertise was performed.

The FDA recommends retaining a qualified consultant. The firm has committed to ceasing trace metal analyses and suspending (b)(4) testing of APIs. The letter requires a comprehensive investigation into data inaccuracies, a risk