Stanley Specialty Pharmacy Compounding and Wellness Center – FDA 483, Oct 1, 2021

This FDA Form 483 document details an inspection observation regarding a pharmaceutical manufacturing facility. The core issue identified is the inadequacy of procedures designed to prevent microbiological contamination of drug products purporting to be sterile.

Specifically, the firm failed to conduct media fills that closely simulate aseptic production operations, particularly under worst-case, most challenging, and stressful conditions. An example provided highlights this deficiency: the current media fill qualification procedure simulates a maximum fill of (b)(4) vials and (b)(4) vials. However, the firm's Lidocaine eye drops formulation (formulary 14891) is filled into 1-ml syringes in quantities between (b)(4) units over an extended duration. This discrepancy indicates that the media fill validation does not accurately represent the actual production scale and duration, potentially compromising the sterility assurance of the drug product. The observation implies a critical deficiency in the firm's quality system related to aseptic process validation, which could have significant business and operational implications concerning product quality and regulatory compliance.