FDA EIR - Ash Stevens LLC - November 04, 2022

An FDA surveillance inspection of Ash Stevens LLC, operating as Piramal Pharma Solutions Riverview, a non-sterile Active Pharmaceutical Ingredient (API) manufacturer, took place from October 31 to November 4, 2022. The inspection was conducted under Compliance Program 7356.002F for API Process Inspections, covering the firm's Quality, Facilities and Equipment, Materials, Production, and Laboratory Systems. Although no formal FDA Form 483 was issued, two significant deficiencies were verbally discussed with company management. Firstly, investigation records lacked consistent documentation of historical reviews for potentially impacted batches or a clear justification when such reviews were not performed for unaffected batches. This issue was particularly noted in investigations involving damaged equipment parts where the impact on previous production was not adequately assessed. Secondly, the scientific justification for selecting swabbing locations to verify cleaning effectiveness was deemed insufficient; these critical areas were identified based on operator experience rather than scientific rationale. Additionally, the practice of simply re-cleaning equipment until passing results were achieved after a failure was highlighted. Ash Stevens LLC management was cooperative throughout the inspection. The firm is expected to address these verbally communicated observations to enhance their quality systems and ensure ongoing regulatory compliance.